Senior Design Quality Engineer I

Johnson & Johnson

Danvers, Massachusetts, United States
$94,000.00 - $151,800.00; not specified; not speci...
Hybrid
Design assurance engineering activities
Risk management and analysis
Design verification and validation
Johnson & Johnson is seeking a Senior Design Quality Engineer I for their Danvers, Massachusetts location, focusing on enhancing the quality of medical devices, specifically single-use heart pumps. The role requires extensive experience in quality assurance within the medical device industry, emphasizing regulatory compliance and risk management

Job Summary

  • This role will 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.
  • Responsibilities include supporting Design Assurance engineering activities for Abiomed's Life Cycle processes, ensuring compliance with FDA QSRs, ISO 13485, and other international quality and regulatory requirements.
  • The company offers a comprehensive benefits package including retirement plans, vacation, sick time, holiday pay, parental leave, and volunteer leave.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Senior Design Quality Engineer I for their Danvers, Massachusetts location, focusing on enhancing the quality of medical devices, specifically single-use heart pumps. The role requires extensive experience in quality assurance within the medical device industry, emphasizing regulatory compliance and risk management.

Salary

$94,000.00 - $151,800.00; Not specified; Not specified

Skills & Requirements

Must-have

  • Design Assurance engineering activities
  • risk management and analysis
  • design verification and validation
  • FDA QSRs and ISO 13485
  • manufacturing process development support
  • statistical analysis and sampling plans

Nice-to-have

  • voice of quality
  • independent decision maker
  • mentor newer QE's
  • challenges current thinking
  • human-centered design

Key Requirements

  • Bachelor degree in Engineering or Sciences
  • Minimum of 8 years of quality experience
  • Medical device industry experience highly preferred
  • Solid understanding of quality engineering policies, principles, standards, and FDA/ISO requirements

Work Rights

Not specified

Tailored Resume

Cover Letter