Quality Assurance Manager - Medical Device - Wheeling, IL

With over 1,600 dedicated employees in 18 different countries, Angiotech is a global specialty pharmaceutical and medical device company. Our tagline “redefining success� describes how Angiotech is striving to create novel medical solutions that elevate the standard of care and improve people’s lives. We are seeking intelligent, progressive, and creative professionals to join our team.

Overview



The QA Manager will support company sales growth objectives by managing and directing the day to day activities of the Q.A. Inspection, Documentation and Engineering functions supporting the manufacturing process and addressing regulatory issues for released products at the Wheeling, ILfacility.

 

ResponsibilitiesProvide support for the operation of the plant by performing a wide variety of work in developing, designing, testing and installing quality assurance systems, work instructions and procedures based on statistical analysis and demonstrated process capabilities to meet established standards and requirements.Actively seek out, recommend and perform studies, testing and evaluations in order to support increases in production, quality, efficiency, volume of products. Maintain an ISO 13485 certified Quality System meeting FDA CFR requirements including accurate Device History Records, Post Market Surveillance systems including a formalized complaint investigation and field action processes and an established system for measuring and quantifying internal and external defects.Supervise direct reports and assigned personnel per company policies and procedures.Work alone, on a team and/or as a team leader.Also has dotted line reporting responsibility to Wheeling Plant Manager.

RequirementsBachelor's degree in Engineering or Business, or equivalent experience.5 to 10 years experience in medical device manufacturing.Utilize computers to analyze data, maintain records, files and complete all required paperwork.Ensure that current Quality Assurance system is in compliance with all applicable standards for ISO 13485 certification and FDA CFR compliance.Maintain documentation and records for all released products in compliance with all applicable standards and regulatory requirements.Must have strong supervisory skills.Fluent in MS Office.

We offer a competitive salary, a competitive bonus compensation program, a full benefits package and the opportunity to grow with a company dedicated to improving healthcare through innovative products.

For more information and to apply directly, please visit our career website: http://www.angiotech.com/careers/and go to our online career center.