Quality Engineer

Job Title:

Quality Engineer

Job Description

The Quality Engineer provides expertise and 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, and global field teams to ensure that all activities comply with internal procedures and applicable geographic regulations. The position requires flexibility to manage changing priorities, the ability to work independently with minimal supervision, and strong leadership in driving quality improvements for electromechanical medical devices.

Responsibilities

+ Lead the product reporting and complaint handling process for assigned products, including initial evaluation, escalation, risk evaluation, investigation, root cause determination, product disposition, and report closure.

+ Manage the returned product analysis process, including decontamination, external vendor sterilization coordination, root cause analysis, and root cause determination, while supporting additional root cause analyses as requested.

+ Lead failure mode determination activities, including coordinating and collaborating with external laboratories when needed.

+ Collect, manage, and analyze data on returned product results and post-market therapy outcomes arising from the product reporting process.

+ Organize and lead cross-functional reviews with Development, Operations, and Manufacturing on emerging quality issues, and participate in the definition and execution of resulting 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, including product performance, therapy performance, safety, and system risk management activities.

+ Lead and participate in post-market risk management reviews with cross-functional teams to ensure risks are minimized and potential corrective and preventive actions (CAPAs) are identified and initiated.

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

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

+ Support internal and external quality management system audits by providing documentation, subject matter expertise, and follow-up actions as needed.

+ Perform design reliability, process, and product quality assurance functions to support robust product performance and compliance.

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

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

+ Comply with applicable quality system procedures and policies, and actively suggest and support 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.

+ Medical device work history, ideally with electromechanical products.

+ Post-market quality engineering experience, including complaint handling and field performance monitoring.

+ Hands-on experience with root cause analysis, risk management, and quality assurance activities.

+ Experience using risk management tools such as Design Failure Mode and Effects Analysis (dFMEA) and Process Failure Mode and Effects Analysis (pFMEA).

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Experience with risk management standard ISO 14971 or equivalent for medical devices.

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Experience with global harmonized task force (GHTF) requirements for process validations and related activities.

+ Knowledge of ISO and FDA Quality System Requirements, including regulations such as FDA 21 CFR Part 820, 821, and 822.

+ Strong project and time management skills with the ability to prioritize and manage multiple tasks concurrently.

+ Demonstrated team leadership skills, including the ability to lead cross-functional teams and drive projects to completion.

+ Demonstrated creative and effective problem-solving abilities and original thinking for compliance and quality solutions.

+ Ability to work independently with minimal supervision and adapt to changing priorities.

+ Proficiency in Microsoft Word, Excel, and PowerPoint for documentation, reporting, and presentations.

Additional

Skills & Qualifications

+ Experience in design reliability, process quality, and product quality assurance functions.

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Experience with Class III active implantable medical devices.

+ Professional certifications from the American Society for…