Job Title: Prin Quality Engineer (Medical Device)
Job Location: Billerica, Massachusetts (Fully onsite)
Type: W2 contract
Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have a broad knowledge of project management. Requires a University Degree and a minimum of 7 years of relevant experience, or an advanced degree with a minimum of 5 years of relevant experience.
Validation Knowledge, Self-Driven, Manufacturing experience.
Work with the engineering team to execute validation, update pFMEA, and update procedure. Problem-solving for process improvement.
What products will this role support? – Disposable – sphere 9 and Capital equipment.
Job Description - Responsibilities may include the following and other duties may be assigned.
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.
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.