Principal Quality Engineer - Katalyst Healthcares & Life Sciences
Billerica, MA 01821
About the Job
Responsibilities:
- Develops, modifies, applies, and maintains quality standards and protocols for processing materials into partially finished or finished materials products.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Devices 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.
- Validation skills (IQ, OQ, PQ, TMV, CSV, Equipment Validation).
- Manufacturing Process Improvements.
- Update pFMEA.
- Any experience working with Disposable Medical Devices/capital equipment is ideal.
Source : Katalyst Healthcares & Life Sciences