JT672 - QUALITY ENGINEER II
- Juncos, PR
- Temporal
- Tiempo completo
- Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
- Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
- Bachelor's degree in engineering (Mechanical, Elecal or Chemical preferred)
- 4+ years of relevant experience
- Experience with Risk management documentation: pFMEAs
- Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory)
- Basic knowledge in statistics (preferably using Minitab)
- Basic knowledge in defining validation strategies (e.g requirements flow down from design to manufacturing)
- Experience investigating manufacturing operations events in support to product disposition
- Experience assessing and tracing manufacturing defects/rejects trends
- Knowledge in Medical Devices regulations
- Experience working and executing Design transfer activities
- Experience with projects to implement new products: design requirements validation, manufacturing controls (not Operational Excellence
- Experience reviewing and approving validation test plans, reports, and deviations
- Capable of performing statistical analysis to support validations and product release
- Available for 1st shift