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Quality Systems Supervisor

2 months ago

Tucson, United States Ethical Search Professionals Full time

Seeking Quality Systems Supervisor with experience in manufacturing process controls with experience in injection molding or contract manufacturing. You will be responsible for regulatory requirements; 21 CFR Par 11, 21 CFR Part 820, ISO-13485, regulatory submissions to the FDA and other regulatory agencies. Ideal candidate will have a degree in a discipline related to regulatory affairs with 5 years experience in a regulatory environment, or in quality systems with emphasis in regulatory submissions, supplier audits and will also oversee quality technicians. Must have experience applying regulatory requirements to a corporate and multi-site company with understanding of the medical device industry directives and the ability to work with FDA and international standards. You will also support validation efforts of the company data-base for quality systems MQ-1, review complaint files for closure and ensure investigations conclusions are clearly documented as part of the record. CAPA compliance with FDA guidelines experience is also a nice to have. LOCAL candidates only to the Tucson, AZ location, and must be authorized to work in the U.S. without sponsorship.

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