Assure cGMP Quality Assurance policies, standards, instructions, and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment for an assigned complex project or area are maintained and product integrity is preserved. Ensure the highest quality levels area achieved and cost‑effective compliance is applied to align with contractual and Company requirements. Provide QA support to operations and engineering programs as assigned. Design and establish workmanship criteria for projects. . Functional team member for assigned work areas to ensure product is shipped on time and per specification. Process non-conforming material reports, engineering change orders, complaints, CAPAs, and assist with training for line personnel. Performs quality on the floor audits and responsible for the maintenance and compliance with program manufacturing/quality plans.
BS degree preferred plus 5 or more years of related experience to be proficient in the above areas; or an equivalent combination of education and experience.
Must have prior experience in Medical Device or Pharmaceutical manufacturing support. Must have FDA and ISO audit experience (13485, 21 CFR 820, 803, 806 and 14971).
Strong, demonstrated ability to think out of the box to provide technically sound Quality Assurance and Quality System solutions to designated programs to achieve business results and maintain high levels of quality and compliance.
Demonstrated experience working with contract manufacturing, suppliers and customers.
Green Belt, Lean, Black Belt proficiency desired.