Product Quality Assurance Manager

AGA Medical Corporation, a medical technology company, is dedicated to the development, design, manufacture, and marketing of nitinol-based occlusion devices and accessories for the minimally invasive treatment of cardiovascular defects and peripheral vascular disease.As a Product Quality Assurance Manager, you will be responsible for product and supplier quality tracking, issues and initiatives and daily maintenance of the Quality System processes that support product quality, including training, product changes and product records. Responsible for product quality including: NCMRs, Issues, trending, Product CAPAs, SPC initiatives, supplier and internal audits. Responsible for all in-process product test and inspection methods and product final release. Responsible for AGA Sterility Assurance program. Responsible for QA lab test: FAI, Special Inspection and verification testing requests and equipment. Responsible for product change and record management. Responsible for corporate-wide training management. Manage staff to implement objectives and maintain quality and throughput. Influence non-QA staff/Management in quality initiatives/objectives. Qualifications: Bachelor’s degree in Engineering or Science, Master's Preferred. 5+ years direct Quality Assurance management experience in a medical device manufacturing facility required. 10 years in the medical device industry. Extensive knowledge with requirements to maintain national and international practices, guidance, standards, regulations (i.e. GMP, CFR, ISO) required. Certifications desired: Certified Quality Manager (CQM), Certified Auditor. Understand lean and 6-sigma processes. Excellent organizational, interpersonal and communication (both written and oral) skills. Ability to coordinate and manage the completion of multiple projects simultaneously. Computer proficiency in MS Word, Excel and Outlook. Ability to constructively interact with a range of personalities and many levels of the organization. -For quick consideration apply here We offer an excellent compensation and benefits package including medical, dental, life insurance, disability, 401(k), and much more. An Equal Opportunity/ Affirmative Action Employer Please, No Agencies Position Information Location: Plymouth, MN Job Category: Quality Assurance/Safety Contact Information reference code: 1173