Position Overview:
The Sr. Quality Engineer is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.
What you will do:
Design Controls & Risk Management- Lead and maintain Design Control deliverables: Design & Development Plans, Design Inputs/Outputs, Design Reviews, Traceability Matrix, DHF updates, and DMR readiness.
- Own and facilitate ISO 14971 risk management: hazard identification, risk analyses (FMEA, dFMEA/pFMEA), risk controls, and risk-benefit rationale; ensure linkage to verification/validation and post-market surveillance signals.
- Define, review, and approve verification & validation (V&V) protocols and reports (including usability, biocompatibility, sterilization, packaging validation, shelf life, transportation, and software validation as applicable).
Test Methods, Measurement & Data Integrity- Develop, validate, and transfer test methods (TMV/MSA: accuracy, precision, repeatability/reproducibility, linearity, bias, gage R&R).
- Establish acceptance criteria using sound statistics (e.g., tolerance intervals, confidence levels, sample size determination, DOE when appropriate).
- Ensure data integrity (ALCOA+) and compliant documentation in eQMS/PLM systems.
Design Transfer & Process Readiness- Partner with Manufacturing Engineering on process characterization (IQ/OQ/PQ), CTQ definition, control plans, and inspection methods.
- Approve FAI for critical components; ensure supplier controls and incoming inspection are aligned to risk.
- Lead line readiness for pilot builds and PP events; facilitate defect prevention (Poka-Yoke, SPC implementation, mistake-proofing).
Regulatory & Standards Compliance- Ensure compliance with 21 CFR 820, ISO 13485, MDSAP, ISO 14971, and applicable standards (IEC 60601, ISO 10993, ISO 11135/11137, ISO 11607, IEC 62366, IEC 62304 for software, etc.).
- Provide quality input to regulatory submissions (510(k), PMA, EU Technical File) including verification summaries, risk files, and labeling controls.
Problem Solving & CAPA- Drive root cause analysis (5-Why, Ishikawa, Fault Tree) and implement CAPA with effectiveness checks.
- Lead defect prevention and continuous improvement using Lean/Six Sigma tools (DMAIC, Kaizen, DOE).
Skills for Success:
- BS Degree required.
- 8+ years as a Quality Engineer required.
- Previous experience in FDA/ISO regulated industry required.
- CQE and CQA preferred.
Physical demands & Travel required
