Design Quality Engineer Ii, Lifecycle

Johnson & Johnson

Danvers, Massachusetts, United States of America
Base: $92,000.00 - $148,350.00; bonus/equity: not ...
Hybrid
Risk management and analysis
Design verification and validation
Fda qsrs and iso 13485
Johnson & Johnson is seeking a Design Quality Engineer II for their Danvers, Massachusetts location to support quality assurance activities in the lifecycle of their medical devices, particularly focusing on heart pumps. Candidates should have a background in quality engineering within the medical device industry and demonstrate strong knowledge of FDA and ISO regulations

Job Summary

  • Perform various Design Quality Engineering functions supporting continuous improvement and innovation of marketed products, including risk management, design verification, design validation, and design assurance activities.
  • Support and lead Design Assurance engineering activities in support of Abiomed’s Life Cycle processes including design controls, quality planning, risk assessments, design reviews, and test method development and validation.
  • Contribute to the design, development and implementation of product assurance plans providing feedback to corrective and preventative actions to engineering, manufacturing, service and field operations and supplier performance.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Design Quality Engineer II for their Danvers, Massachusetts location to support quality assurance activities in the lifecycle of their medical devices, particularly focusing on heart pumps. Candidates should have a background in quality engineering within the medical device industry and demonstrate strong knowledge of FDA and ISO regulations.

Salary

Base: $92,000.00 - $148,350.00; 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, retirement plan (pension) and savings plan (401(k))

Skills & Requirements

Must-have

  • Risk management and analysis
  • Design verification and validation
  • FDA QSRs and ISO 13485
  • Medical device quality engineering
  • Product lifecycle support

Nice-to-have

  • Voice of quality
  • Independent decision maker
  • Mentor newer QE's
  • Challenges current thinking

Key Requirements

  • Bachelor degree in Engineering or Sciences
  • Minimum of 3 years of quality experience
  • Experience in medical device industry
  • Experience in cardiovascular devices
  • Knowledge of FDA/ISO requirements

Work Rights

Not specified

Tailored Resume

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