Senior Quality Assurance Engineer – Medical Device

My client is a leading innovator in medical device technology, specializing in cutting‑edge, laser‑powered solutions that advance patient care. Their mission is to push the boundaries of what’s possible in healthcare through groundbreaking innovation, precision engineering, and a deep commitment to improving clinical outcomes.

If you’re passionate about making a real impact in the world of medical technology, this is your opportunity to join a purpose‑driven team that’s shaping the future of healthcare one innovation at a time.

The Sr. Quality Assurance Engineer will collaborate with suppliers, development teams, and manufacturing teams to perform QA activities. This includes, but is not limited to, supporting Design Transfer processes and ensuring quality standards are met throughout the product lifecycle.

• Provide manufacturing quality engineering leadership to manufacturing and sustaining engineering.
• Support SCAR processes and manage nonconformances and rework evaluations for assigned suppliers.
• Handle supplier‑related internal NCMRs, CAPAs, and complaint corrective actions.
• Provide sustaining support for process improvements and design changes transitioning into manufacturing.
• Assist in design transfer activities and maintain manufacturing documentation (DHRs, routers, BOMs, specifications).
• Investigate and disposition material nonconformances; participate in MRB meetings and follow up on supplier issues.
• Perform incoming inspection reviews and disposition of components and subsystems.
• Maintain and create product‑specific risk files in accordance with ISO 14971.
• Develop and revise procedures, work instructions, and test methods.
• Support CAPA processes and promote QMS awareness and improvement initiatives.
• Participate in internal and supplier audits.

• Bachelor's degree in engineering or a related technical field.
• 5–7 years of manufacturing quality experience within the medical device industry.
• Experience executing process validation and test method validation / Gage R&R activities.
• Experience with risk management activities per ISO 14971.
• Working knowledge of advanced statistical methods, including Hypothesis testing, Design of Experiments (DOE), ANOVA, R&R studies, Capability analysis, Tolerance interval analysis, Power and sample size determinations.
• Supplier management experience is preferred.
• Proficiency with statistical software tools (e.g., Minitab) is preferred.
• Extensive working knowledge of 21 CFR Part 820, ISO 13485.