Principal Quality Engineer
GForce Life Sciences
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Principal Quality Engineer
4-month contract - potential to extend
Onsite in Newton, MA
Key Responsibilities:
- Act as the Quality subject matter expert for Incoming Inspection and Supplier Quality on new product development teams.
- Develop and implement procedures for inspecting, testing, and evaluating components, materials, and products.
- Create test plans and inspect materials using dimensional and attribute criteria.
- Select and validate optimal measurement tools and inspection sampling plans (AQL-based).
- Apply quality engineering tools such as FMEA, DOE, root cause analysis, and statistical methods (e.g., Six Sigma).
- Lead the development of visual and functional inspections for mechanical, electrical, injection-molded, and packaging components.
- Support equipment calibration processes and retrieval of calibrated devices for production use.
- Investigate non-conformances and manage root cause analysis from MRBs, RMAs, and CAPAs.
- Trend and analyze quality data from NCMRs and RMAs.
- Participate in supplier audits and site visits.
- Support manufacturing transfers, including documentation (DMR/DHR) and validation (IQ/OQ/PQ).
- Perform other quality-related tasks as assigned.
Qualifications:
- Bachelor's degree in Engineering, Biomedical Engineering, or Life Sciences.
- 10+ years of quality engineering experience in the medical device industry, especially with electro-mechanical devices.
- Strong background in new product development and design controls.
- Hands-on experience with metrology, inspection tools, and test method development.
- In-depth knowledge of QSR, ISO 13485, ISO 14971, and EU MDR.
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Contract
Job function
Job function
Engineering, Quality Assurance, and Other-
Industries
Medical Equipment Manufacturing
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