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Responsibilities:
1. Support supplier transfer projects and serve as primary liaison for all actions associated with new supplier requirements.
2. Transfer of components and raw materials to new suppliers.
3. Continuously monitor risk of the existing suppliers / components and define risk mitigation plans.
4. Support the transfer of product improvements into production utilizing Design for Manufacturing (DFM) principles.
5. Lead analysis of defective components in Incoming Inspection and work with vendors to resolve.
6. Manage supplier process validation activities by applying a risk based approach.
7. Implement continuous improvement within supply chain.
8. Lead / support the supplier evaluation process when selecting & qualifying new suppliers, help maintain the ASL, supplier scorecards, and supporting documentation required per SOPs.
9. Resolve incoming inspection yield issues by driving tighter vendor process capabilities and ensuring appropriate internal drawing tolerances.
10. Ensure compliance of manufacturing processes and areas to all applicable quality system regulations.
11. Monitor and analyze production information to support risk management and to provide direction for corrective and preventive actions and/or process improvement activities (CAPA).
12. Validate manufacturing and supplier processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
13. Work with manufacturing engineering and supply chain to ensure necessary process controls and validations are in place and best practices are followed (GMP).
14. Identify key process input variables and key process output variables.
Qualifications:
1. Bachelor's Degree, preferably in Mechanical, Plastics or Manufacturing Engineering.
2. 5+ years of professional experience involving technical interaction with vendors.
3. Knowledge of polymer, machining, metal cutting processes, and / or electronics fabrication.
4. Manufacturing and supplier quality control experience.
5. Experience with formal problem-solving methodologies and deductive skills.
6. Experience with handling non-conforming material and assemblies, including root cause investigations pertaining to such non-conformities.
7. Experienced in qualification of production equipment and verification of production processes.
8. Utilized statistical data analysis for trending purposes, ideally utilized Six Sigma methods and tools.
9. Knowledge of process qualifications (validations, verifications, IQ, OQ, PQ).
10. Knowledge of Process Capability and data analysis using statistical tools (Six Sigma Green or Black Belt is a plus).
11. Project Management experience.
12. Demonstrated critical thinking in fast paced environment.
13. Basic understanding of medical device regulatory requirements.
14. Basic understanding of metrology.
15. Willingness to travel up to 25-50%, primarily to visit suppliers.