Senior Quality Engineer

4 weeks ago


Minneapolis, United States Lumicity Full time

Exciting Senior Quality Engineer Opportunity with a fast-growing Medical Device Company

**This is not a Software Quality Engineering position and only open to US permanent residents/green card holders**

My client is a Medical Device company looking for a Senior Quality Engineer that has extensive experience in the Medical Device Industry. The ideal candidate is someone who has a strong quality engineering background with Medical Device industry or manufacturing/injection molding industry.

This is a great leadership and management opportunity with a company that prioritizes career-growth and has an exciting future within the Medical Device Industry.

Qualifications

  • Bachelor's degree in engineering or a science-related degree
  • 5+ years of experience in the Medical Device industry
  • CQE (preferred)
  • Knowledge of ISO and FDA requirements: ISO 13485, FDA 21 CRF Part 820
  • Lean Six Sigma

Responsibilities

  • Ensure that medical devices meet regulatory requirements and meet the highest standards of quality
  • Developing, implementing, and maintaining the Quality Management System to ensure compliance with regulatory requirements and standards
  • Managing relationships with suppliers and ensuring that all materials and components used in the manufacturing of medical devices meet quality standards
  • V&V, CAPA, non-complaint, and continuous improvement processes
  • Train and lead team of Quality Engineers

Benefits

  • Competitive Salary: $95k - $125k
  • Company Benefits such as:
  1. Employer Medical Plan
  2. Relocation Assistance
  3. PTO & Paid Holidays
  4. 401k with company match
  5. Tuition Reimbursement


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