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A Progressive and Exciting Workplace

At Acumed, the people who work here are our most valuable asset. By providing a dynamic environment that supports individual growth and responsibility, we’ve been able to hire, and retain some of the brightest minds in healthcare. We believe strongly that each of our employees makes an impact on the lives of the patients who receive our products. Which is why we encourage everyone within the company to push the limits of their expertise, whether it’s in engineering, production, inspection, marketing, or regulatory and compliance. Personal health and happiness are highly valued at Acumed, and we devote a significant amount of resources to ensure it. We provide benefits that enhance medical care, help plan for the future and promote general well being.

Acumed is currently hiring for a variety of positions. To apply for an open position, please visit our careers portal.

Benefits Include . . .

  • Generous PTO
  • Medical, dental, and life insurance
  • Short and long-term disability insurance
  • 401(k)
  • Nine paid holidays
  • Retirement plan
  • Flexible spending accounts
  • Educational assistance
  • TriMet bus pass subsidy
  • Costco membership subsidy
  • Gym membership subsidy
  • An employee referral program
  • Bike room and showers

Current Open Positions

Position Location Department Posted Onsort descending
Senior Quality Engineer Hillsboro, OR, USA Quality Mar. 04, 2015

Job Purpose/Scope

This position has the responsibility and authority to provide Quality Assurance Engineering representation to Product Development teams. This position owns the risk management profile for products during their entire lifecycle, including risk identification, completion, and management of risk mitigation activities. Participates in facilitation of initial product design, development, design transfer to manufacturing, and process improvements to obtain optimum product reliability, safety, and effectiveness. Coordinate feedback of quality indicators and statistics to organization for use in business decisions. Partner with Operations and Engineering in process improvements.
Responsible for quality planning and the overall quality of new products being released to the market through participation in product development to ensure product and process conformance to global standards (including FDA and ISO 13485). Performs, directs, or consults in process and design validations. Provides QA approval for changes to design, test methods, and test equipment to assure the design and production of medical devices are in compliance with applicable standards. Drives investigations, corrective action implementation, and corrective action verification activities as assigned.
Position is also responsible to aide in the identification, documentation and subsequent testing of all design requirements identified by all internal and external customers, including end users, purchasing organizations, and regulators.

Duties/Responsibilities
• Provide quality leadership in product development teams to the entire design lifecycle of Acumed products to ensure compliance with Acumed policies and global regulations, including FDA Quality System Regulation and ISO 13485. The design lifecycle includes design control, design verification and validation, design transfer, process validation, risk management, and specification development.
• Coordinate with Regulatory staff members to ensure that product testing and design requirements for intended markets are identified, part of the product requirements as documented in the Design History File, and met during the product development. Represent the needs of the Regulatory team during product development.
• Guide teams to ensure robust application of appropriate design and manufacturing controls.
• Educate project teams on requirements related to regulations, procedures, and requirements. Provide training, guidance and interpretation.
• Ensure quality and completeness of project design history files, risk management files, validation packages, and change orders.
• Provide ongoing quality engineering support throughout the product life cycle, including risk management, design and manufacturing changes, and CAPA investigations.
• Lead all risk management activities for products throughout their lifecycle, including risk identification, completion, and management of risk mitigation activities.
• Be a strong representative for Quality and Regulatory concerns during technical discussions and risk-based decision making; ensure issues are resolved using a risk-based approach.
• Monitor the quality and performance of new products to ensure requirements are met and product is performing as anticipated. Identify concerns, develop a risk-based solution with impacted departments and lead implementation efforts, as appropriate.
• Drive the creation and approval of verification and validation reports and identify gaps for compliance with Acumed policies and global regulations. Develop and execute strategies to close gaps in an efficient, technical, and compliant manner.
• Deliver appropriate quality metrics to the organization to identify opportunities and drive improvements. Consult with end users and process owners on data collection, analysis and reporting.
• Identify opportunities, develop solutions, and support implementation of improvements to the design and development process. Support continuous improvement efforts.
• Report status updates on assigned responsibilities and goals; timely escalation of issues
• Other activities as assigned.

Qualifications

• Bachelor's degree in an engineering or science discipline; advanced degree preferred
• 5-7 years of experience working in quality assurance role in a regulated environment. Experience working with implantable devices preferred.
• Experience applying quality regulations and standards (e.g. 21 CFR 820, ISO 13485, ISO 14971, Medical Device Directive, etc.)
• Experience with CAPA and failure investigation tools and techniques.
• Applied experience with quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, trend analysis, etc.)
• Knowledge of ERP Systems (SAP preferred) and advanced Microsoft Office; expert level Microsoft Excel skills.
• Certified Quality Engineer (or equivalent) preferred.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Quality Manager, Acute Innovations Hillsboro, OR, USA Acute Mar. 05, 2015

The Quality Manager for Acute Innovations is responsible for directing Quality Assurance activities to support all aspects of Quality programs. They build successful teams, develop and lead people to achieve continuous improvement and drive change throughout the organization.

Acute Innovations is a subsidiary of Acumed.

Duties/Responsibilities
-Management representative for the quality system, which maintains compliance to FDA/QSR requirements.
-Oversee quality and inspection operations.
-Coordinate the inspection and quality duties throughout company.
-Assure ongoing compliance to the Quality Assurance Manual.
-Support and participate in the quality objectives within the company.
-Supervise Quality personnel.
-Qualifies and monitors vendors.
-Reviews, approves, verifies, and participates in Corrective Action.

Qualifications/Requirements
-B.S. in Engineering or related field
-Thorough knowledge and experience in FDA, CMDCAS, ISO, and MDD
requirements and consensus standards.
-5+ years of quality assurance experience preferred
-Experience in the medical device or equivalent industry (quality or
medical device engineering)

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Program Manager Hillsboro, OR, USA Project Management Mar. 18, 2015

The Program Manager oversees all project management activities for the Company's new and sustaining products, ensuring successful launches and delivery of new products within budget, scope, schedule and customer satisfaction requirements. The Program Manager reports to the Vice President of Product Development & Product Management and works closely with the leadership team to develop and execute to the APLC (Acumed Product Life Cycle) for both US and International products.

This position offers a robust relocation package for the right candidate!


Duties/Responsibilities
•Oversees the development and implementation of project management activities related to the Company's launch and sustaining product goals.
•Oversees the development and management of budgets for product-related projects and programs.
•Assigns, manages and directs resources for NPI project management programs; creates and adheres to NPI Resourcing Model.
•Prioritizes key NPI and APLC programs and presents regular status and progress reports to leadership. 
•Ensures coordination and alignments between department leadership and SMEs to ensure appropriate levels of resourcing and achievable schedules to meet company objectives and milestones.
•Identifies and implements systems to bring consistency across Project and Program management disciplines and activities.
•Defines and manages metrics for continuous improvement and accountability.
•Manages and reports out on overall project costs and performance to budgets.


Qualifications
• Bachelor's degree required with a preference for a BS degree in Mechanical, Manufacturing, Industrial Engineering or related field. MBA desirable.
• 5+ years of experience in product development and/or manufacturing, with a minimum of 3 years as a project manager in the medical device field or in a related area.
• Demonstrated experience leading and directing project/program managers effectively
• Demonstrated ability to establish and manage P/L of project development costs and provide summaries to executive members.
• CAPM (Certified Associate in Project Management) and /or PMP (Project Management Professional) preferred.

 

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

International Marketing Manager Hillsboro, OR, USA Marketing Apr. 08, 2015

The Marketing Manager supports the achievement of revenue goals by developing strategies and programs to increase the adoption of on-market products and to optimize the launch of new products in partnership with Product Management. In order to ensure that the strategies and programs developed will be effective, the Marketing Manager conducts market research to understand targeted customer groups, industry trends and competitive strategies. By providing oversight over how Acumed's product marketing initiatives come together, the Marketing Manager will also work closely with the Marketing Communications team to ensure that all advertisements, PR, on-line promotional strategies, etc. align with the annual regional marketing plan.


Duties/Responsibilities
• The Marketing Manager aligns individual product marketing plans generated by Product Management to develop a marketing plan for their assigned region.
• Implements annual regional marketing plan and budget that effectively supports the sales organization achieve its annual revenue goal.
• Ensures marketing communications are coordinated, support marketing plan objectives and meet organizational expenditure requirements.
• Conducts primary and secondary market research to drive improved customer insights and understanding of industry trends, compiles and analyzes data for use by product management and sales. Refines marketing plan based on data analysis.
• Assesses competitive strengths and weaknesses and consolidates the data for use by product management.
• Using market research, helps define target customer and develops programs and tools that will facilitate the acquisition of new customers and the retention of current customers.
• Using market research, helps define and communicate Acumed vs competitive positioning to ensure market competitiveness. 
• Supports new product launch priorities working with RBMs to define each product's Distribution Plan. 
• Maintains relations with agents through frequent communication that helps us better understand their needs and how we can increase their focus on selling Acumed products.


Qualifications
• BA/BS in Business or related field required; Master's in Business Administration preferred.
• Minimum of 3 years of experience in marketing; at least 2 years of experience with medical products or medical devices highly preferred.
• Orthopaedic, trauma, dental, or spine experience highly preferred.
• Knowledge of business development principles related to strategic planning and resource allocation.
• Demonstrated track record of success in developing marketing plans and managing marketing processes.
• Demonstrated strategy, communication, and presentation skills.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

CNC Machinist Hillsboro, OR, USA Production Apr. 08, 2015

The Operator / Machinist produces medical devices using manual and CNC equipment.

Acumed offers a robust benefits package for all full-time employees, including Paid Time Off, 401(k) match, affordable healthcare, and more!

Shift: Swing Shift M-Th 3:00pm - 1:30am


Duties/Responsibilities
•Uses established practices to ensure Quality during operation including documentation and techniques.
•Monitors machine performance.
•Performs preventative maintenance as required.
•Performs general set-ups to ensure maximum utilization.
•Troubleshoot problems under the guidance of Senior Machinists.
•Work with Process Engineers to improve Cell processes.


Qualifications
•Generally requires 2-4 years CNC equipment operating experience.
•Ability to operate machine tools safely and understand set-up instructions.
•Familiar with basic blueprint reading or ability to acquire blueprint reading skills.
•Familiar with basic Inspection techniques and processes, or ability to learn and understand them.
•High School diploma or equivalent

 

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Distribution Manager Hillsboro, OR, USA Supply Chain Apr. 08, 2015

Provide analytical, technological, and logistical support managing consigned Acumed inventory, Main inventory, and Acumed's planning and logistics systems. Help design, specify, and implement systems to support sales growth while ensuring best in class inventory utilization performance across all Acumed's inventory. These systems include: AIMS, Agency processes and best practices, Acumed integration to hospital systems and processes, International consignment, consigned inventory forecasting, multi-warehouse distribution and loaners. Build strong relationships with Sales, Sales Business Services, Agent Inventory, Logistics, Planning and IT to achieve goals and objectives. Recommend and support all Supply Chain groups in their execution of inventory initiatives as they relate to availability, turns, new product rollouts, upgrades and obsolescence.


Duties/Responsibilities
• Identify, develop and implement technology to optimize inventory management, control, and increased visibility.
• Evaluate best in class hospital inventory systems and processes to drive internal systems development and implementation.
• Develop and maintain inventory management procedures, processes, and systems that integrate internal and external requirements.
• Collaborate with Agent Inventory and Planning to develop and maintain forecasting systems.
• Monitor and summarize territory usage of systems to enhance the management consignment inventory and optimize utilization.
• Help define optimal utilization rates by product to communicate performance benchmarks for Agents in collaboration with Product Management, Sales, and Agent Inventory.
• Help automate and improve regional inventory measurements to determine appropriate inventory approval levels including turn metrics and net inventory changes.
• Monitor and make recommendations regarding centralized inventory activity, stocking levels, and kit configurations.
• Develop strong working relationships and working knowledge with supply chain internal and external customers and suppliers (such as warehouses, carriers, logistics groups, etc.).
• Analyze and report on revenue results, forward looking trends, and other metrics to measure and track the success of our distribution and sales strategy.


Qualifications
• Bachelor's degree in Business Administration, Economics, Engineering, Supply Chain, Logistics or related field required. Master's degree preferred.
• 5+ years of professional experience with 3+ years plus experience in a supply chain role (Distribution Planning, Master Production Scheduling, Materials Planning, or Demand Planning).
• APICS certification preferred.
• Experience with SAP, or other ERP system, and Microsoft Office (proficient with Word, Excel, and Outlook).

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Instructional Designer Hillsboro, OR, USA Medical Education Apr. 10, 2015

The Instructional Designer develops and designs curriculum and content for Medical Education and Sales Training programs for Acumed personnel and customers to promote the safe use of our products, increase product knowledge, and sales techniques. This position combines in-depth knowledge of adult learning theory and skill development, various forms of instructional media, and facilitation expertise. The Instructional Designer develops an entire curriculum from individual courses to entire programs, with multiple coursework. Keeps abreast of emerging instructional design theory, instructional technologies, and developments in technology enhanced learning tools by participating in professional development and research activities.

Duties/Responsibilities
• Develop training objectives roadmap for overall curriculum structures and develop education plans for each project. Design and implement the process for curriculum planning and course development.
• Develop project proposals including budgets, timelines as part of curriculum development process.
• Design, develop and implement e-learning and classroom training for various target audiences using appropriate writing styles to make content easy to understand. 
• Create online self-paced training modules that reinforce key anatomy, procedure, and product objectives.
• Analyze learning aims and objectives and work with Subject Matter Experts (SMEs) to design solutions that align with learner and business needs. Apply instructional design theories and practice.
• Develop training on competitive product initiatives to ensure field salesforce can respond to competitive product offerings.

Qualifications
• Bachelor's degree in Education, Clinical (R.N. RPh) or Technical area such as engineering or science required. MS in Instructional Design & Development or Education preferred
• 3 or more years of experience developing educational content at the corporate level
• Prior curriculum design experience required; Instructional Design & Development or Education preferred.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Business Services Specialist Hillsboro, OR, USA Customer Service Apr. 22, 2015

Business Services Specialists receive questions from customers and follow established procedures to provide answers or refer calls to appropriate staff. The Business Services Specialist ensures that good customer relations are maintained, and complaints are resolved fairly and effectively, and in accordance with Acumed procedures. Assists senior and lead staff on order status, product information, account status, pricing, product or service.


General Duties/Responsibilities
• Professionally handle incoming requests
• Ensure that issues are resolved both promptly and accurately
• Thoroughly and efficiently gather customer information
• Resolve billing issues and shipping discrepancies
• Gather documentation and complete various forms for resolution
• Efficiently and accurately enter customer orders
• Provide quality service and support in a variety of areas
• Receive and record customer complaints professionally and accurately
• Other job-related duties as assigned


Qualifications
• High School diploma required. (Associates or bachelor's degree preferred)
• Minimum of 1-2 years customer service experience required
• Exceptional people skills – project a positive, professional image at all times
• Excellent verbal, written and telephone skills supported by strong interpersonal skills and ability to work within a team structure
• Ability to work under a high stress environment, maintain composure and adhere to daily deadlines
• Effectively resolve problems and answer questions in a clear and concise manner
• Ability to multi-task (i.e. simultaneously answer multiple phone calls and process orders) and manage time effectively

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Process Engineer Hillsboro, OR, USA Process Engineering Apr. 22, 2015

The Process Engineer (PE) supports production cells and new product development teams to meet operational objectives by developing, integrating, and improving production processes and systems. The Process Engineer also ensures compliance to Acumed, FDA, and ISO regulations.

Duties/Responsibilities
• Develop and implement advanced production fixtures
• Develop new production Routes, Bill of Materials (BOMs), and Inspection Plans via ECOs
• Manage Quality Notification (QN) system and disposition all non-conforming product
• Support corrective/preventative action activities (CAR/SCAR)
• Prepare and analyze quality metrics to identify repeated quality issues
• Lead cell level Process Improvement (PI) initiatives and implement Lean tools
• Develop manufacturing plans and timelines for new product release
• Review new product design for manufacturability prior to production release
• Coordinate Pilot Production Runs and conduct production readiness reviews (PRR)
• Develop and execute Process Validation protocols and reports
• Implement and improve upon existing manufacturing processes

Qualifications
• 2-6 years process engineering or related experience
• Applied 3D CAD experience in Autodesk Inventor, Solidworks, PRO-E or equivalent
• Applied understanding of Geometric Dimensioning & Tolerancing (GD&T)
• Applied understanding of Process Validation (IQ, OQ, & PQ) requirements
• Understanding of statistical tools such as control charts, trending, and capability
• Experience in the Medical Device industry desired
• Knowledge of FDA and ISO 13485 Regulations
• Understanding of Risk Management and experience with tools such as FMEA

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Finisher (Day Shift) Hillsboro, OR, USA Production Jun. 23, 2015

The Finisher finishes products according to approved prints through means of tumbling, deburring, polishing and/or blasting processes. This is a great opportunity to expand your manufacturing skillset!

This position is on a day shift schedule (M-Th 5:00am - 3:30pm).

General Duties/Responsibilities
• Maintain Acumed's high quality standards. Know, understand, and follow all SOP's and WI's. 
• Continual focus on customer service (Quality, Cost & Delivery), lean manufacturing concepts, and process improvement activities. 
• Accurately and thoroughly complete appropriate paperwork, and computer transactions with minimal supervision. 
• Conduct preventive maintenance on finishing equipment with general supervision.
• Assist with monitoring supply levels – inform appropriate personnel when supplies are low.
• Complete individual finishing projects (tumbling, deburring, polishing and blasting).

Qualifications
• High School Diploma/GED or equivalent. 
• Experience in metal finishing (hand and machine) and media blasting preferred but not required. 
• Experience with machine operation preferred but not required.
• Basic mechanical aptitude, good hand-eye coordination, and detail-oriented.
• Ability to read and understand blueprints. Basic math skills.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Quality Assurance Technician Hillsboro, OR, USA Production Jun. 23, 2015

The Quality Assurance Technician inspects material, products, or processes, purchased or manufactured, to the required drawing or print specification, or other controlling document.

This position is assigned to a mid-day shift.


Duties/Responsibilities
• Perform first article dimensional and documentation inspections.
• Audit In-process records, receiving inspection documentation, final inspection documentation, and other quality or manufacturing data for accuracy and completeness.
• Evaluate inspection processes for improvement using standard problem solving and improvement techniques (i.e. Redundant inspections, improved techniques and instructions).
• Actively participate in Manufacturing Cell teams as a Quality representative by addressing quality-related issues per documented processes.
• Accurately enter information into manufacturing data gathering system.
• Maintain and update Quality system documentation, such as work instructions, procedures, in-process inspection information, and other related documentation.
• Address and follow-up on quality-related issues between departments (i.e. Manufacturing Engineers, Design, Quality Engineers, Planning, Manufacturing).
• Demonstrate an understanding of final acceptance activities.
• Create Non-Conforming Material Reports (NCMR's) as needed.
• Participate in MRB (Dispositions – NCMR).
• Maintain calibration of gages and integrity of calibration system by accurately entering information.
• Track the status of receiving inspections (FIFO, Visual Indicators).


Qualifications
• High School Diploma/GED or equivalent
• Two years manufacturing experience required; 1 or more years of experience in manufacturing inspection preferred.
• Ability to read and speak English sufficiently to read work instructions, specifications and procedures and complete all paperwork.
• Ability to use precision measuring equipment including micrometers, calipers, gage pins, optical comparators, and other inspection equipment.
• Ability to read and understand engineering drawings and specifications related to manufactured products.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Finisher (Swing Shift) Hillsboro, OR, USA Production Jun. 25, 2015

The Finisher finishes products according to approved prints through means of tumbling, deburring, polishing and/or blasting processes. This is a great opportunity to expand your manufacturing skillset!

This position is on a swing shift schedule (M-Th 3:00pm - 1:30am).

General Duties/Responsibilities
• Maintain Acumed's high quality standards. Know, understand, and follow all SOP's and WI's. 
• Continual focus on customer service (Quality, Cost & Delivery), lean manufacturing concepts, and process improvement activities. 
• Accurately and thoroughly complete appropriate paperwork, and computer transactions with minimal supervision. 
• Conduct preventive maintenance on finishing equipment with general supervision.
• Assist with monitoring supply levels – inform appropriate personnel when supplies are low.
• Complete individual finishing projects (tumbling, deburring, polishing and blasting).

Qualifications
• High School Diploma/GED or equivalent. 
• Experience in metal finishing (hand and machine) and media blasting preferred but not required. 
• Experience with machine operation preferred but not required.
• Basic mechanical aptitude, good hand-eye coordination, and detail-oriented.
• Ability to read and understand blueprints. Basic math skills.

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Senior Regulatory Affairs Specialist Hillsboro, OR, USA Regulatory Jun. 26, 2015

The Senior Regulatory Specialist will function as the regulatory representative in the product development process to develop and execute product strategies. The Specialist will provide training and support for internal stakeholders, external customers, and the relevant competent authorities. In addition, the Specialist will perform local country surveillance for assigned regulatory activities. Also, the Regulatory Specialist will ensure all records and systems supporting regulation are adequately maintained and compliant to current regulations.

Duties/Responsibilities
• Must have a self-driven ability to investigate and understand regulations. Senior-level employee that works well independently and with a team, depending on the situation requirements.
• Initiate and maintain required establishment listings for FDA, EU MDD and CMDCAS including renewal or changes
• Initiate and maintain accurate international product registration, including renewal or changes, and certificates for foreign governments
• Manage correspondence with the regulatory and standards agencies or organizations such as FDA, MDD Notified Body, Health Canada, ISO, Acumed's EU Authorized Representative
• Prepare, organize, coordinate content/data and ensure regulatory compliance for submission to the FDA or regulatory agencies (e.g. 510(k), PMA, MDD Technical Files/Design Dossiers, global registration applications, etc.)
• Ensure all processes for the essential functions are documented in procedures
• Review and disposition ECRs/ECOs for potential impact to new and existing registrations.
• Review of all Product labeling to assure compliance with registrations.
• Assist in determination of appropriate product testing to support registration activities.
• Determine the best strategy to register new products in specific global markets

Qualifications
• Bachelor's degree required in Regulatory Affairs, Biology, Chemistry, Engineering, or related field
• 3-5+ years of related experience required
• Evidence of applied knowledge of applicable FDA, CMDCAS, ISO, MDD, region-specific requirements and consensus standards
• Ability to work with FDA, Notified Body, EU Authorized Representative and other global regulatory agencies
• Able to manage multiple projects simultaneously
• Proven track record of strong team work, creatively strategic thinking
• Ability to work well with others, support regulatory activities and mentor/train others
• Excellent written and verbal communication skills

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Senior Graphic Designer Hillsboro, OR, USA MarCom Jun. 26, 2015

The Senior Graphic Designer combines graphic design and marketing to create marketing materials that represent the Acumed brand. The Senior Graphic Designer leads the design process and participates in strategy development for promotional materials to support events, trainings, product launches and corporate promotional campaigns.


Duties/Responsibilities
• Designs complex or difficult projects using expertise and knowledge to graphic design principles.
• Serves as the lead designer to turn visualizations into comprehensive designs that extend brand messaging across multiple media channels to deliver effective marketing materials within budget guidelines.
• Maintain and promote the Acumed Global Brand/Identity Guide.
• Manage project workload for quality and adherence to deadlines. 
• Work with US and International Marketing Managers to understand market segments and develop marketing promotions to target them.
• Collaborates effectively to evaluate, identify and recommend opportunities to strengthen the Acumed brand and amplify customer brand experience.
• Develops and produces creative brand designs to ensure imagery and messaging promotes Acumed's brand identity.

Qualifications
• BS/BA in Graphic Design or related field required 
• 4 years or more experience in graphic design
• Manage multiple priorities, be detailed focused, and highly organized

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.

Quality System Analyst Hillsboro, OR, USA Quality Jun. 26, 2015

The Quality System Analyst (QSA) administers the Corrective and Preventive Action Program (CAPA), the Internal Quality Audit System, and Field Actions related to implicated product. The QSA implements and maintains the Acumed quality system in compliance with applicable regulations. Promote continuous improvement culture and ensure compliance with applicable regulations. The QSA drives integration of various quality systems to ensure continuous compliance with global quality system requirements and ensures processes that support the quality system are robust and support the evolving requirements of Acumed's product line.


Duties/Responsibilities
• Owns and executes all aspects of CAPA program administration ensuring compliance with the quality standard. CAPA program administration includes authoring, updating, and driving compliance with standard operating procedures (SOPs), work instructions (WIs), and forms. 
• Respond to CAPA requests and open new CAPAs when appropriate.
• Verify CAPAs are thoroughly investigated and accurately documented in the system.
• Review all CAPAs prior to closure to assure all required actions were completed; perform effectiveness checks at established intervals in a timely manner.
• Partner with senior leadership to ensure CAPAs are appropriately resourced for closure within a reasonable timeframe.
• Owns and executes all aspects of Acumed's Internal Quality Audit system administration ensuring compliance with the quality standard. Internal Audit system administration includes authoring, updating, and driving compliance with standard operating procedures (SOPs), work instructions (WIs), and forms. 
• In collaboration with the Quality Manager, create, distribute, and maintain the annual internal audit schedule.
• Coordinate with leaders in other departments to ensure sufficient auditing resources are available to support the audit schedule.
• Mentor and develop Acumed employees in other departments as internal auditors; coordinate required external certification to qualify internal auditors.
• Manage the creation and approval of Health Hazard Evaluations (HHEs) ensuring input and agreement from stakeholders
• Analyze HHEs in preparation for management review.
• Create, maintain, and disseminate reports and metrics on CAPA system activities, Internal Quality Audit system, and Field Actions for management.


Qualifications
• Bachelor's degree in an engineering or science discipline; advanced degree preferred
• 5-10 years of experience in a quality role in medical device manufacturing.
• Working knowledge of applicable Code of Federal Regulations and ISO 13485.
• Extensive knowledge of Quality System Regulation, US FDA, and ISO 13485. Experience with international quality system regulations preferred.

 

To apply, please visit our applicant registration page

Acumed is a drug-free environment and an equal-opportunity employer.