Director, Quality Assurance NeoMend
THIS JOB HAS EXPIRED The Director, Quality Assurance is responsible for ensuring that Neomend has Quality Assurance systems that comply with the FDA?s quality system regulations (21CFR 820, 806, 803, 210, 211), ISO 13845, relevant international quality system standards, Division and Corporate procedures (as required) and customer expectations. This position develops and manages the Quality Assurance systems in efficient and effective support of the business objectives of Davol and CR Bard. Responsibilities include ensuring that all Neomend colleagues understand and execute their responsibilities within the quality system. The Director, Quality Assurance is the Management Representative for the Company.
The successful candidate will have a minimum of 10 years quality assurance experience in the medical products industry, experience with FDA and Notified Bodies quality system inspections, and Professional certification preferred ( ASQ CQA, CQE, C Q. Mgr, CQA-Biomedical, RAC). A Bachelor?s degree in engineering or science, or other related field, Master?s/Ph.D. in appropriate discipline is
preferred. Excellent communication, interpersonal skills and experience in managing manufacturing quality assurance in the medical device industry are required. Must have demonstrated success in developing progressive and compliant quality systems and maintaining excellent positive relationships with regulatory agencies.
||9272 Geronimo Drive |
Irvine, CA 92618
THIS JOB HAS EXPIRED