The Quality Engineer will be responsible for providing quality engineering support for manufacturing. The ideal candidate should have experience supporting complex electro-mechanical, software-controlled systems for medical applications. This individual will work with engineering teams within the company. This position requires knowledge of medical device regulatory environment (FDA, MDD, ISO 13485). Candidates should also have knowledge and experience to support Design for Reliability and Manufacturability (DRM), Design for Six Sigma, Design for Lean Six Sigma, Testing requirements like TMV and test protocol development, and risk management per ISO 14971 and other standards like IEC60812 and AIAG.
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
Apply and understand statistical methodologies, as appropriate, for conformity assessment and investigative activities to resolve potential product and quality system opportunities for improvement.
Review equipment and process validations, changes, nonconformances, etc., in order to ensure compliance and assess the impact on product reliability, process capability and compliance status.
Review and approve test method validation and stability plans and reports.