Engineer II, Device Quality
About The Position
The Device Quality and Risk Management Engineer supports medical device quality and risk management activities for existing and new products throughout the product lifecycle. Under the guidance of senior quality and risk management personnel, the role assists with design controls, risk management, quality system compliance, investigations, CAPA, supplier quality, and regulatory inspections. The position collaborates with cross-functional teams to support risk-based decision-making and help ensure device products comply with FDA QMSR, ISO 13485, EU MDR, and internal quality system requirements. The role contributes to design and development documentation, quality review of product deliverables, device manufacturing and supplier quality activities, and risk assessments. It also supports audits, inspections, continuous improvement, and monitoring of quality and risk management metrics. The incumbent is expected to maintain awareness of evolving regulations and industry practices, apply research and professional development to quality activities, and follow company Health, Safety, and Environmental guidelines.
Requirements
- Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline.
- At least three years of experience in medical device, combination product, pharmaceutical, or other regulated manufacturing environments.
- Working knowledge of FDA Quality System Regulation (21 CFR Part 820/QMSR), ISO 13485, ISO 14971, EU MDR, and related regulatory requirements.
- Familiarity with risk management methodologies, including FMEA, Hazard Analysis, FTA, or similar risk assessment tools.
- Experience supporting quality system processes such as investigations, CAPA, change control, validation, supplier quality, document control, or design controls.
- Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
- Strong written and verbal communication skills and ability to collaborate across cross-functional teams.
- Strong analytical, problem-solving, technical writing, and organizational skills.
- Ability to manage multiple priorities and work effectively in a fast-paced, regulated environment.
- Initiative and self-motivation, with the ability to work independently and seek guidance when appropriate.
- Commitment to ongoing professional development and review of relevant regulations, standards, guidance, scientific literature, and industry practices.
- Ability to research, interpret, and apply regulatory requirements, industry standards, and emerging best practices.
Responsibilities
- Support medical device quality system activities, including developing and maintaining Design and Development Files, to meet applicable regulatory, standards, and internal quality system requirements.
- Assist with quality review of design and development plans, deliverables, and associated documentation throughout the product lifecycle.
- Support quality activities related to device manufacturing, assembly, testing, packaging, labeling, and component suppliers.
- Review and contribute to procedures, protocols, reports, batch records, technical files, and other quality documentation for accuracy and inspection readiness.
- Participate in lifecycle risk management activities, including developing, reviewing, and maintaining risk management documentation.
- Assist cross-functional teams with risk management methodologies such as FMEA, FTA, HAZOP, and Hazard Analysis, and support risk assessment updates as circumstances or requirements change.
- Support risk assessments associated with deviations, CAPAs, complaints, nonconformances, and OOS investigations; escalate quality and compliance concerns as appropriate.
- Participate in internal audits, supplier audits, and regulatory inspections, including documentation, risk management records, responses, and follow-up activities.
- Support continuous improvement by collecting, analyzing, and reporting quality and risk management data and metrics.
- Observe Company Health, Safety, and Environmental guidelines.
- Use quantitative reasoning and demonstrate professionalism, commitment to excellence, customer focus, attention to detail, communication, and teamwork.
- Demonstrate initiative by expanding technical knowledge and seeking opportunities to improve device quality and risk management activities.
- Maintain awareness of evolving regulatory requirements, industry standards, guidance documents, scientific literature, and industry publications.
- Apply research, professional development, and industry benchmarking to support continuous improvement, regulatory compliance, risk-based decision-making, and operational excellence.
- Perform other assignments as necessary.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
