Manufacturing Quality Engineer
1 week ago
Responsibilities:
Product/ process requirements management (40%):
Support pre-production operations, such as design transfer, process development, validation, and R&D gate reviews. Participate, review, and approve pFMEA, measurement system analysis (MSA), and inspection method. Responsible for the Process Control Plan and the inspection/test instruction for the products developed by S+N Medical (Shanghai). Coach, review, and approve the SOPs/WIs established by the contract manufacturer. Support change control activities.Process performance (40%):
Collaborate with the Contract Manufacturer process performance, such as yield rate or performance capability- Ppk monitoring. Supervise quality control-related matters from supplier. Review DHR and support product release as needed.Continuous Improvement (20%):
Lead, coach, review, and approve root cause investigation and its CAPA associated with product complaints/ adverse events. Support GMP/ ISO13485 audits for production, participate in Surveillance or Recertification Audits, and follow up on the closure of process gaps.Qualifications:
Bachelor’s degree in engineering, science, or related discipline.
5+ years of experience in medical device manufacturing quality, NMPA- MAH requirement, ISO13485, statistical software (e.g., Minitab)
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