Sr Quality Engineer

Location: North Haven, CT (Onsite)
Duration: 12 Months
Experience: 57+ Years
Pay Range: $50-55/hr on W2

• Support PLM system implementation ensuring compliance with quality and design control requirements
• Review/approve PLM workflows, documentation, and quality records
• Support validation, risk management, and data migration activities
• Partner with Quality, R&D, Manufacturing, Regulatory, and IT teams
• Maintain continuity of quality operations during system transition
• Assist with routine Quality Engineering activities (CAPA, NCR, Change Control)

• Strong experience in Medical Device QMS:
  • Change Control, Document Control, CAPA, Nonconformance
  • ISO 13485 compliance
• Hands-on experience with PLM / eQMS systems:
  • (Windchill, Teamcenter, Agile, etc.)
  • Workflow review, validation, data migration
• Experience working cross-functionally and supporting audits

• Medical device industry experience (required in practice)
• Experience with system implementation or digital quality transformation

• BS in Engineering or Science (preferred)