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- 5+ years related Medical Device experience, or equivalent combination of education and experience.
- Develop and maintain QA plans and process routings, which reflect intended/actual activities.
- Provide support for all quoting activities by participation in initial process design, development, and implementation phases.
- Evaluate and support inspection processes via inspection aids and instruction guidelines.
- Support all training programs by development and implementation of specialized training sessions for all applicable functions.
- Conduct periodic review and maintenance of all documentation files; develop appropriate systems for document storage and access.
- Review all supplier or customer discrepancies. Coordinate and track the
- Writes and executes engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation).
- Performs gage design, measurement system analysis, and gage implementation as required. Is able to use various types of measuring instruments including, micrometers, calipers, comparators, tensile testers, coordinate measurement systems etc. to support engineering testing.
- Leads and participates in investigations, develops plans and executes tasks to solve process problems including Nonconformances (NC), complaint investigations, audit observations and Corrective and Preventive Actions (CAPA).
- Provides day to day support and direction to production such as, but not limited to turning, milling, drilling, EDM, finishing, packaging etc. as required.
- Identifies and implements process improvements for existing manufacturing processes utilizing appropriate engineering principles and standard strategies such as, Lean and Six Sigma principles.
- Develops fixtures and designs tools and has the ability to express and implement ideas with tool designers.
- Supports new equipment acquisition efforts including user requirement specifications, machine selection, installation, validation, employee training, and other related equipment responsibilities as required.
- Develops and implements manufacturing and inspection procedures.
- Participates in, and, in some cases, leads cross-functional teams which may include, but are not limited to Manufacturing Engineering, Production, Quality Assurance, Finance, and Product Development.
- Acts as a liaison to vendors with regard to contracted products, tools & fixtures, and their manufacture.
- Performs other related duties, as required and NPI related experience is a must
- ID: #49901765
- State: New Mexico Albuquerque 87101 Albuquerque USA
- City: Albuquerque
- Salary: Depends on Experience
- Job type: Contract
- Showed: 2023-05-10
- Deadline: 2023-07-02
- Category: Et cetera