Quality Engineer

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

+ 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.

+ 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.

+ Lead failure mode determination activities, including collaboration with external laboratories when necessary.

+ Collect, manage, and analyze data related to returned product results and post‑market therapy outcomes generated from the product reporting process.

+ Organize and lead cross‑functional reviews with Development, Operations, and Manufacturing on emerging quality issues and participate in defining and implementing corrective actions.

+ Work with Operations to obtain product returns from the field and initiate warranty replacements as appropriate.

+ Lead and participate in post‑market reviews covering product performance, therapy performance, safety, and system risk management.

+ Lead and participate in post‑market risk management reviews with cross‑functional teams to minimize risks and initiate potential corrective and preventive actions (CAPAs).

+ Lead and support cross‑functional teams to resolve quality issues and drive completion of CAPAs.

+ Generate and approve design history file documents, device master record documents, engineering change orders (ECOs), and other quality management system (QMS) records.

+ Support internal and external QMS audits by preparing documentation, participating in audit activities, and following up on findings.

+ Perform design reliability, process quality, and product quality assurance functions as needed.

+ Document product and therapy‑related field reports within prescribed timelines and provide all necessary documentation to support investigations, including follow‑up reporting.

+ Complete required training and competency confirmations within established timelines and maintain up‑to‑date knowledge of relevant procedures.

+ Comply with applicable quality system procedures and policies while actively suggesting and supporting continuous process improvements.

+ Effectively prioritize, execute, and report on multiple concurrent projects and tasks in a dynamic environment.

Essential Skills

+ 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.

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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.

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