Senior Quality Engineer - Medical Devices

Our client, a leading Medical Device company, is seeking an experienced Quality Engineer for its growing team. The ideal candidate will have experience with sustaining operations quality support, adhering to regulatory requirements and NCR ownership. See below for other details:

• Data driven problem solving
• Solid understand and application of regulatory requirements
• NCRs, Complaint Investigation, Site Transfers, Site Shutdowns

• Day to day sustaining operations quality support
• NCR Ownership
• Complaints DHR and manufacturing assessment

• 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.

Bachelor's Degree within an Engineering realm and 4+ years of applicable experience