Agile Programming Methodologies, Business Continuity Planning (BCP), Change Control, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Migration, Document Control, Document Management, Documentation, ISO (International Organization for Standardization), Maintain Compliance, Manufacturing Requirements, Medical Equipment, Product Lifecycle Management, Quality Control, Quality Engineering, Quality Management, Research & Development (R&D), Risk Management, Teamcenter, Windchill PLM Software
Sr Quality Engineer – Medical Device (PLM Implementation)
Location: North Haven, CT (Onsite)
Duration: 12 Months
Experience: 5–7+ Years
Pay Range: $50-55/hr on W2
Core Responsibilities
- 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)
Must-Have Skills
- 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
Preferred
- Medical device industry experience (required in practice)
- Experience with system implementation or digital quality transformation
Education
- BS in Engineering or Science (preferred)