Principal Quality Engineer

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Direct message the job poster from GForce Life Sciences

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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