Quality Engineer II
Medtronic Inc
Quality Engineer II supporting surgical sutures manufacturing at Medtronic's North Haven facility. Develops quality standards, collaborates cross-functionally on process compliance, and implements inspection and testing procedures to ensure medical device reliability and regulatory adherence.
Responsibilities
- Develop, modify, and maintain quality standards and protocols for material processing
- Collaborate with engineering and manufacturing to establish and enforce quality requirements
- Design inspection and testing mechanisms; conduct quality assurance tests and statistical analysis
- Implement corrective measures and ensure documentation meets regulatory compliance
- May specialize in design, incoming materials, production control, or product evaluation quality areas
Requirements
- Bachelor's degree in Engineering, Science, or technical field plus 4+ years engineering/quality experience
- Advanced degree in Engineering/Science with 2+ years relevant experience, or PhD
- Process validation experience including IQ, OQ, TMV, and PQ
- CAPA (Corrective Action/Preventive Action) methodology experience
- Strong written and verbal communication skills
- Experience in fast-paced manufacturing environments
Vacancy posted 1 day ago
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