Affinity Executive Search
Quality Systems Supervisor
Affinity Executive Search, Tucson, Arizona, United States, 85718
Seeking
Quality Systems Supervisor
with experience in manufacturing process controls, specifically in injection molding or contract manufacturing. You will be responsible for regulatory requirements including 21 CFR Part 11, 21 CFR Part 820, ISO-13485, and 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 of experience in a regulatory environment, or in quality systems with an emphasis on regulatory submissions and supplier audits. You will also oversee quality technicians.Must have experience applying regulatory requirements to a corporate and multi-site company, with an 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 database for quality systems MQ-1, review complaint files for closure, and ensure investigation 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.Excellent company benefits!
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Quality Systems Supervisor
with experience in manufacturing process controls, specifically in injection molding or contract manufacturing. You will be responsible for regulatory requirements including 21 CFR Part 11, 21 CFR Part 820, ISO-13485, and 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 of experience in a regulatory environment, or in quality systems with an emphasis on regulatory submissions and supplier audits. You will also oversee quality technicians.Must have experience applying regulatory requirements to a corporate and multi-site company, with an 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 database for quality systems MQ-1, review complaint files for closure, and ensure investigation 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.Excellent company benefits!
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