About this opportunity
GForce Life Sciences lists this Principal Quality Engineer opportunity in newton, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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Executive MSP Recruiter at GForce Life Sciences
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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Inferred from the description for this job
Medical insurance
Vision insurance
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Worksite address
newton, MA, 02165, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.