Quality Engineer - Medical Devices

Please note:

This is an onsite role in North Haven, CT

Our client, a leading Medical Device company, is seeking an experienced Junior level Quality Engineer for its growing team - This role will provide quality engineering support for projects including: documentation support, execution of DR, IQ, PD, TMV, OQ, PQ, NCMR, CAPA, PFMEA /Risk Assessment, and coordination of all validation quality testing.

• 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.

• 2+ years of experience with process validation, root cause analysis and statistical analysis
• Bachelor's Degree within an Engineering realm