Quality Engineer

Quality Engineer

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 include:

• Leading 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.
• Managing 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.
• Leading failure mode determination activities, including collaboration with external laboratories when necessary.
• Collecting, managing, and analyzing data related to returned product results and post-market therapy outcomes generated from the product reporting process.
• Organizing and leading cross-functional reviews with Development, Operations, and Manufacturing on emerging quality issues and participating in defining and implementing corrective actions.
• Working with Operations to obtain product returns from the field and initiate warranty replacements as appropriate.
• Leading and participating in post-market reviews covering product performance, therapy performance, safety, and system risk management.
• Leading and participating in post-market risk management reviews with cross-functional teams to minimize risks and initiate potential corrective and preventive actions (CAPAs).
• Leading and supporting cross-functional teams to resolve quality issues and drive completion of CAPAs.
• Generating and approving design history file documents, device master record documents, engineering change orders (ECOs), and other quality management system (QMS) records.
• Supporting internal and external QMS audits by preparing documentation, participating in audit activities, and following up on findings.
• Performing design reliability, process quality, and product quality assurance functions as needed.
• Documenting product and therapy-related field reports within prescribed timelines and providing all necessary documentation to support investigations, including follow-up reporting.
• Completing required training and competency confirmations within established timelines and maintaining up-to-date knowledge of relevant procedures.
• Complying with applicable quality system procedures and policies while actively suggesting and supporting continuous process improvements.
• Effectively prioritizing, executing, and reporting on multiple concurrent projects and tasks in a dynamic environment.

Essential skills include:

• Minimum of 2+ years of experience in a quality or design function within the finished medical device industry.
• Hands-on medical device work history, ideally with electromechanical devices.
• Strong work history in post-market quality engineering, including complaint handling, product reliability, and product quality assurance.
• Demonstrated experience in root cause analysis and risk management for medical devices.
• Experience using risk management tools such as dFMEA, pFMEA, and fault tree analysis (FTA).
• Experience applying the medical device risk management standard ISO 14971.
• Knowledge of global harmonization task force (GHTF) requirements for process validation and related activities.
• Solid understanding of ISO standards and FDA Quality System Requirements, including FDA 21 CFR Part 820, 821, and 822.
• Experience with quality systems management and quality management systems in a regulated environment.
• Ability to perform design reliability assessments and process and product quality assurance functions.
• Demonstrated team leadership skills with the ability to prioritize, execute, and report on projects.
• Strong project management and time management capabilities, with the ability to handle multiple tasks concurrently and adapt to changing priorities.
• Proven creative and effective problem-solving skills and original thinking in developing compliance solutions.
• Proficiency with MS Word, Excel, and PowerPoint.
• Ability to work independently without direct supervision while maintaining high standards of accuracy and compliance.

Additional skills and qualifications include:

• Experience working with Class III active implantable medical devices.
• Experience in design reliability engineering, process validation, and product quality assurance functions.
• ASQ certifications such as CRE, CQM, CQE, or CQA are…