Supplier Quality Engineer - Medical Devices
Job Description
This Engineer will directly support two high-profile CMOs, resolving quality issues and driving process efficiency for critical device components, including injection molded and single-use disposable products. The role requires a technically sound, hands-on problem solver who can collaborate with CMOs and internal teams to maintain product integrity, meet production goals, and ensure customer satisfaction.
Must Haves:
- 6+ years in supplier quality or manufacturing engineering
- 4+ years hands-on experience with injection molding in a regulated environment
- Proven success working with multiple CMOs to resolve quality issues and improve efficiency
- Strong technical mindset with root cause analysis and problem-solving skills
- Experience handling high-profile, high-pressure issues with measurable results
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Key Responsibilities:
- Serve as the quality engineering lead for multiple CMOs, focusing on injection molding and disposable products
- Resolve customer-impacting quality issues, working directly with CMOs to implement permanent fixes
- Partner with CMOs to improve processes, reduce defects, and maintain compliance with quality standards
- Manage high-profile escalations, collaborating with cross-functional teams to ensure timely resolution
- Support design transfer and product introduction projects to CMOs, ensuring quality readiness and alignment
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)