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Job #02855

About our client Our client is a world-leading healthcare company that has developed a reputation for successfully bringing impacting products to market in a variety of therapeutic areas. The company has some of the strongest financial indicators in the industry, an experienced management team and a robust pipeline. They also offer an empowering corporate culture that is focused on the professional development and advancement of clinical team members. Position Location Quality Assurance Manager Iowa Salary Highly competitive package, commensurate with experience Responsibilities 1) Ensure company compliance with quality processes as per all applicable ISO, FDA and other regulations 2) Handle document management 3) Follow-up on open items such as CAPA, internal audits, change control plans, etc. 4) Audit potential and existing suppliers for compliance with GMP and other regulations 5) Support audits from customers, suppliers and regulatory authorities 6) Assist with reviewing product labeling 7) Create and file paperwork to maintain existing registrations 8) Respond to information requests from international distributors 9) Research documentation from technical files to support questions and registrations 10) Help assemble quality documentation for new products 11) Assist with product registrations in the US and other countries 12) Conduct internal training on quality procedures (as needed) 13) Perform other duties as assigned Requirements 1) Degree (4 year) 2) Minimum 3 years of process improvement, quality and/or operations experience 3) Experience in the Quality Department of an ISO-certified company (drug, medical device, cosmetics, or consumer products company preferred) 4) Auditing experience a plus 5) Working knowledge of ISO 9001, ISO 13485, Medical Device Directive, GMP, FDA drug, medical device, cosmetic regulations and CPSC regulations an asset 6) Excellent MS Office skills (including Word, Excel and Visio) 7) Detail-oriented and organized with attention to quality 8) Ability to work with others to accomplish objectives 9) Ability to review regulations and determine necessary actions 10) Excellent communication skills and ability to produce high-quality documentation 11) Willingness to travel occasionally (domestic and possibly international)