Sr Quality Engineer

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 4+ years' experience (or Master's with 2+ 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, 8D, 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.