Senior Supplier Quality Engineer, Med Tech & NPI Leadership
Overview
Senior Supplier Quality Engineer leads supplier quality and new product introduction for medical devices at Actalent in the Chicago area. This contract role blends supplier oversight, sustaining engineering, project management, and quality improvement across contract manufacturers. You will collaborate with internal teams and external suppliers to ensure compliant, scalable manufacturing and rapid time to market. The role offers hybrid work with local travel and occasional international travel, shaping quality systems and supplier performance.
What You'll Do10
- 1Build relationships with contract manufacturers to resolve manufacturing issues and drive corrective actions
- 2Lead supplier-related projects including process transfers, IQ/OQ/PQ validations, and capacity expansions
- 3Drive CAPA execution and MRB activities to sustain quality across suppliers
- 4Partner with Quality and Engineering teams to monitor KPIs and improve efficiency, capacity, and product quality
- 5Support new product introduction through supplier selection, RFQ development, and manufacturing readiness planning
- 6Coordinate supplier performance management across quality, delivery, and cost metrics and implement improvement initiatives
- 7Conduct supplier compliance activities and participate in supplier audits and performance reviews
- 8Provide sustaining engineering support including root cause analysis and investigation of quality issues
- 9Collaborate with cross-functional teams to align on regulatory, quality, and customer requirements
- 10Assist in risk management and change control processes for supplier-related activities
Requirements10
- 1Tenure requirement: 10+ years of relevant experience in supplier quality or medical device manufacturing
- 2Experience with contract manufacturers and supplier quality management in the medical device sector
- 3Strong capability in CAPA, MRB, root cause analysis, and quality systems
- 4Involvement in IQ/OQ/PQ validations, process transfers, and capacity expansions
- 5Ability to support NPI through supplier selection, RFQ development, and manufacturing readiness planning
- 6Excellent cross-functional collaboration with Quality and Engineering teams
- 7Understanding of regulatory and customer requirements relevant to medical devices
- 8Willingness to travel locally up to 20% and occasional international travel
- 9Hybrid work arrangement based in Elk Grove Village, IL
- 10Contract role with competitive hourly pay and benefits eligibility
Salary Insight
$55 - $70k per year
Location
Required Skills
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