Principal Quality Engineer

GForce Life Sciences; Newton (MA); On-site; USD 75,000 - 85,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

Job summary

A leading company in medical equipment manufacturing is seeking a Principal Quality Engineer for a 4-month contract in Newton, MA. The role involves ensuring quality standards in new product development, applying engineering tools, and leading inspections. Ideal candidates will have extensive experience in quality engineering within the medical device sector, particularly with electro-mechanical devices, and a solid educational background in engineering or life sciences.

Qualifications

• 10+ years of quality engineering experience in the medical device industry.
• Strong background in new product development and design controls.

Responsibilities

• Act as the Quality subject matter expert for Incoming Inspection and Supplier Quality.
• Develop and implement procedures for inspecting, testing, and evaluating components.

Skills

Quality Engineering

Metrology

Root Cause Analysis

Statistical Methods

Six Sigma

Education

Bachelor's degree in Engineering

Biomedical Engineering

Life Sciences

Job description

5 days ago Be among the first 25 applicants

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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