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 , ISO-, 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...