Job Description
The Quality Engineer provides expert leadership in post‑market surveillance for finished medical devices, with a strong focus on root cause analysis, risk assessment, failure mode determination, product reliability, and ongoing product performance monitoring. This role collaborates closely with Development, Operations, Manufacturing, Quality functions, and global field teams to ensure activities comply with established procedures and applicable geographic regulations. The position requires flexibility in managing changing priorities, the ability to work independently with minimal supervision, and a commitment to continuous improvement in product quality and patient outcomes.
Responsibilities
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Lead the product reporting process for complaint handling across all products, including initial evaluation, escalation, risk evaluation, investigation, root cause determination, product disposition, and report closure.
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Manage the returned product analysis process, including coordination of decontamination, external vendor sterilization, detailed root cause analysis, and root cause determination, while supporting other root cause investigations as requested.
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Lead failure mode determination activities, including collaboration with external laboratories when necessary.
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Collect, manage, and analyze data related to returned product results and post‑market therapy outcomes generated from the product reporting process.
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Organize and lead cross‑functional reviews with Development, Operations, and Manufacturing on emerging quality issues and participate in defining and implementing corrective actions.
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Work with Operations to obtain product returns from the field and initiate warranty replacements as appropriate.
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Lead and participate in post‑market reviews covering product performance, therapy performance, safety, and system risk management.
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Lead and participate in post‑market risk management reviews with cross‑functional teams to minimize risks and initiate potential corrective and preventive actions (CAPAs).
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Lead and support cross‑functional teams to resolve quality issues and drive completion of CAPAs.
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Generate and approve design history file documents, device master record documents, engineering change orders (ECOs), and other quality management system (QMS) records.
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Support internal and external QMS audits by preparing documentation, participating in audit activities, and following up on findings.
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Perform design reliability, process quality, and product quality assurance functions as needed.
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Document product and therapy‑related field reports within prescribed timelines and provide all necessary documentation to support investigations, including follow‑up reporting.
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Complete required training and competency confirmations within established timelines and maintain up‑to‑date knowledge of relevant procedures.
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Comply with applicable quality system procedures and policies while actively suggesting and supporting continuous process improvements.
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Effectively prioritize, execute, and report on multiple concurrent projects and tasks in a dynamic environment.
Essential Skills
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Minimum of 2+ years of experience in a quality or design function within the finished medical device industry.
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Hands‑on medical device work history, ideally with electromechanical devices.
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Strong work history in post‑market quality engineering, including complaint handling, product reliability, and product quality assurance.
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Demonstrated experience in root cause analysis and risk management for medical devices.
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Experience using risk management tools such as dFMEA, pFMEA, and fault tree analysis (FTA).
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Experience applying the medical device risk management standard ISO 14971.
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Knowledge of global harmonization task force (GHTF) requirements for process validation and related activities.
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Solid understanding of ISO standards and FDA Quality System Requirements, including FDA 21 CFR Part 820, 821, and 822.
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Experience with quality systems management and quality management systems in a regulated environment.
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Ability to perform design reliability assessments and process and product quality assurance functions.
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Demonstrated team leadership skills with the ability to prioritize, execute, and report on projects.
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Strong project management and time management capabilities, with the ability to handle multiple tasks concurrently and adapt to changing priorities.
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Proven creative and effective problem‑solving skills and original thinking in developing compliance solutions.
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Proficiency with MS Word, Excel, and PowerPoint.
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Ability to work independently without direct supervision while maintaining high standards of accuracy and compliance.
Additional Skills & Qualifications
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Experience working with Class III active implantable medical devices.
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Experience in design reliability engineering, process validation, and product quality assurance functions.
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ASQ certifications such as CRE, CQM, CQE, or CQA are highly desirable.
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Formal training in ISO standards and quality systems.
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Experience with industry standards such as IEC and EN standards relevant to medical devices.
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Auditing experience, including internal or external quality system audits.
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Certification as an auditor through recognized bodies is an advantage.
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Familiarity with cleanroom environments and process validation in regulated manufacturing settings.
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Experience with product quality monitoring and post‑market surveillance for medical therapies.
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Strong communication skills for effective interaction with cross‑functional teams and global field personnel.
Job Type & Location
This is a Contract position based out of Minneapolis, MN.
Pay and Benefits
The pay range for this position is $43.00 - $53.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Minneapolis,MN.
Application Deadline
This position is anticipated to close on Aug 5, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
