Sr Quality Engineer

Job description :

• We are seeking a Senior Quality Engineer to support process development, manufacturing quality, and compliance for implantable cardiac and neuromodulation medical devices.
• This role focuses on inspection optimization, process and test method validation, and continuous improvement within a regulated medical device manufacturing environment.
• Roles & Responsibilities :
• Lead Inspection Optimization projects (manual, automated, and semi-automated inspection)
• Support equipment development, IQ / OQ / PQ, process characterization, and validation
• Develop and execute Test Method Validation (TMV), including Gage R&R / MSA
• Ensure compliance with FDA, ISO, and GMP quality requirements
• Support CAPA, nonconformance investigations, change control, and risk management (pFMEA / dFMEA)
• Drive quality metrics, scorecards, and continuous improvement initiatives
• Collaborate cross-functionally with manufacturing, process, and design teams.
• Education & Experience :
• Bachelor's degree in Engineering with + years' experience (or Master's with + years.
• Strong experience in medical device manufacturing quality.

• Hands-on knowledge of IQ / OQ / PQ, TMV, DOE, SPC, and statistical analysis.
• Expertise in structured problem solving (DMAIC, D, Ishikawa).
• Excellent technical documentation and communication skills.
• Proficiency with Microsoft Office tools.
• Experience in microelectronics / electronics manufacturing (SMT, wafer, IC assembly).
• Six Sigma / Lean / DFSS certification.
• Experience supporting FDA, MDSAP, or TUV audits.