Sr Quality Engineer - Med Device Contract Manufacturer - Boston

Boston Permanent USD80,000 - USD100,000
  • Work with a world leader of medical contract manufacturing
  • Terrific team culture with abundant upwards mobility

About Our Client

My client focuses on small, precise medical device components for large-scale medical projects. With a focus on ISO 13485 certifications, they are continuing to provide the most accurate service at the highest quality.

Job Description

  • Maintain applicable quality systems, environmental, and FDA requirements/certifications.
  • Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.
  • Proficient in full and proper Geometric Dimensioning & Tolerancing (GD&T) application, and blueprint reading.
  • Determine/improve inspection methods/instructions and incorporate them into the manufacturing processes and Inspection Plans.
  • Prepare and maintain FMEA's, control plans, quality plans, and PPAP.
  • Coordinate process validations and reduce dependence on inspection.
  • Generate applicable quality metric reports; cost of quality, management by facts.
  • Investigate customer complaints including associated actions including CAPA, deviations, and complaint responses.
  • Demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations, Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements, and standard problem solving techniques.
  • Works with Engineering to conceptualize and develop gauging. Applies basic statistical and Six Sigma concepts and techniques.
  • Maintain knowledge of all procedures, changes to specifications and new regulations related to areas of responsibility.
  • Conduct internal audits and support external audits.

A much more in depth job description will be provided upon application and consideration. Please submit your resume for consideration within 48 hours. Relevant candidates can expect to hear back within 48 hours of submission.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

The successful Quality Engineer will have the following:

  • Bachelor's degree with engineering focus preferred or equivalent combination of education and experience
  • ISO 13485, CAPA, Validations and customer interaction experience required.
  • ASQ CQE Certification Preferred
  • Six Sigma Black belt certification, preferred
  • Manufacturing Operations - machining and/or forging
  • Regulations - FDA, GMP and ISO Regulations
  • Metrology
  • Blue Print Reading / GD&T
  • Problem solving and 8D
  • Must be able to read and interpret engineering drawings, ANSI-Y-14.5 dimensioning and tolerancing
  • Knowledge of ANSI-Z1.4 and 1.9 lot sampling

What's on Offer

Our client is offering:

  • Competitive Base Salary and benefits
  • Potential Work-From-Home capacity
  • Upper management exposure to promote upwards mobility

Please reach out to Cameron Cyker with any questions. Apply below today:

Cameron Cyker
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Job summary

Engineering & Manufacturing
Sub Sector
Six Sigma, Lean, Process improvement
Industrial / Manufacturing
Contract Type
Consultant name
Cameron Cyker
Job Reference