Job Information
LISI Medical Remmele Supplier Quality Engineer in Big Lake, Minnesota
Position Summary: This position is responsible for assisting production, ensure that product and service from vendors and supplier are align with standards, managing the supplier performance and the CAPA/NCR linked to his/her scope of activities, leading Change Request, assuring compliance to and providing guidance regarding interpreting ISO 13485, FDA and applicable standards/requirements in link with the Supplier Quality Engineer activities. The Supplier QE is working with the Manufacturing QE and QA Technicians and the Quality inspectors (QAR). Key Responsibilities: This position is primary responsible for: 1. Evaluates, investigates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues 2. Reviews and approves supplier corrective action plans and verification of effectiveness documentation 3. Coordinates the evaluation of proposed changes at suppliers 4. Plans and leads audits of suppliers to assess compliance with regulatory and Lisi Medical Remmele requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up 5. Proactively assesses supplier capabilities through direct on-site visits and technical discussions 6. Collaborate with cross-functional new product development teams to onboard suppliers 7. Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations 8. Generates and maintains incoming inspection procedures 9. Assists in generating component specifications, Develops acceptance criteria for materials 10. Approve Supplier on the ASL and maintain accurate documentation related to supplier quality activities. 11. Lead and monitor Suppliers performance assessment 12. Statistical technics and 8D problem solving SME.