Quality Systems Supervisor

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Quality Systems Manager

We are currently seeking a Quality Systems Supervisor with expertise in manufacturing process controls, specifically in the fields of injection molding or contract manufacturing. In this role, you will have the responsibility of ensuring compliance with various regulatory requirements such as 21 CFR Par 11, 21 CFR Part 820, ISO-13485, and regulatory submissions to the FDA and other regulatory agencies. Ideally, our ideal candidate will possess a degree in a discipline related to regulatory affairs, as well as a minimum of 5 years of experience within a regulatory environment. Additionally, experience in quality systems with a focus on regulatory submissions, supplier audits, and oversight of quality technicians is highly desired.
Your role will involve applying regulatory requirements to a corporate and multi-site company setting and will require an understanding of the medical device industry directives. You will be responsible for working alongside the FDA and international standards, with the intention of supporting the validation efforts of our company’s quality systems MQ-1 database. Furthermore, you will be expected to review complaint files for closure, ensuring that investigation conclusions are thoroughly documented as part of the record. Experience in CAPA compliance with FDA guidelines is seen as an additional asset in this position.
Applicants must be based in Tucson, AZ and should have current authorization to work in the United States without the need for sponsorship.
In return, we offer excellent company benefits!

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