Sr Manufacturing Quality Engineer

Abiomed

Danvers, Massachusetts, United States of America
Base: $79,000.00 - $127,650.00; bonus/equity: not ...
Quality system regulations compliance
Non-conformance investigations
Process validation
Support manufacturing life-saving medical devices in a 'Patients First!' culture to ensure the highest quality standards

Job Summary

  • Support manufacturing life-saving medical devices in a 'Patients First!' culture to ensure the highest quality standards.
  • Provide quality engineering support for new and existing equipment and facilities, ensuring compliance with quality system regulations.
  • Collaborate with manufacturing engineering on process controls and validations, supporting process optimization and quality management systems.

Matching Summary

Support manufacturing life-saving medical devices in a 'Patients First!' culture to ensure the highest quality standards.

Salary

Base: $79,000.00 - $127,650.00; Bonus/Equity: Not specified; Benefits: Vacation, Sick time, Holiday pay, Work/Personal/Family time, Parental Leave, Bereavement Leave, Caregiver Leave, Volunteer Leave, Military Spouse Time-Off

Skills & Requirements

Must-have

  • Quality system regulations compliance
  • Non-conformance investigations
  • Process validation
  • Risk management
  • GMP adherence

Nice-to-have

  • Patients First culture
  • Facility expansion support
  • Process optimization
  • Data analysis skills

Key Requirements

  • 2-4 years QA/QE experience in medical device
  • FDA QSRs, ISO13485, ISO14971 knowledge
  • Bachelor's degree in Engineering

Work Rights

Not specified

Tailored Resume

Cover Letter