Quality Engineer - Medical Device

Westford, MA, US • Posted 1 day ago • Updated 1 day ago
Contract W2
Contract Independent
No Travel Required
On-site
Depends on Experience
Fitment

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Job Details

Skills

  • Quality Management
  • Quality Assurance
  • Risk Assessment
  • Six Sigma
  • ISO 13485
  • Medical Devices
  • Manufacturing
  • QMS

Summary

Role: Quality Engineer

Location: Westford, MA (100% Onsite)

Experience Required:

  • 2–5 years of Quality Engineering experience
  • Experience in Medical Device Manufacturing preferred
  • Pharma or Electronics industry candidates (regulated environment) are also acceptable

Key Responsibilities:

  • Support post-market quality engineering activities for medical devices
  • Maintain risk documentation and support risk reviews
  • Perform complaint investigations and failure analysis
  • Manage CAPA (Corrective and Preventive Actions) processes
  • Develop and execute inspection plans (incoming, in-process, final)
  • Support design change evaluations and documentation updates
  • Handle non-conforming materials and participate in MRB activities
  • Collaborate with suppliers and internal teams on quality-related issues
  • Assist in internal audits and quality system improvements
  • Track and report quality metrics

Required Skills:

  • Risk Assessment & Risk Review
  • CAPA Management
  • Complaint Handling & Investigation
  • Documentation & Change Management
  • Problem Solving (DMAIC / Six Sigma preferred)
  • Inspection Process Development

Regulatory Knowledge:

  • FDA Quality System Regulation (QSR)
  • ISO 13485
  • Quality Management Systems (QMS)

Additional Requirements:

  • Strong problem-solving skills and the ability to work independently
  • Organized and detail-oriented
  • Ability to quickly adapt and contribute to projects
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91125331
  • Position Id: 8921352
  • Posted 1 day ago
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