St. Paul, MN, 55145, USA
24 days ago
Compliance Specialist
Compliance Specialist Regulatory Affairs St. Paul, MN, US Pay Rate Low: 80000 | Pay Rate High: 90000 + Added - 23/08/2024 Apply for Job **_Job opportunity at major medical device company! Our client is looking for a Compliance Specialist to join their ever-growing team._** **Pay:** $80,000-90,000/yr **Location:** St. Paul, MN **Schedule:** Monday-Friday 8:00am-5:00pm **Key Responsibilities:** + Drive supplier selection, qualification, and ongoing monitoring activities. + Support and manage Supplier Corrective and Preventive Action plans and projects to improve quality performance of a supplier. + Identify and monitor material nonconformances and issue and promptly communicate and resolve supplier-related problems + Develop and prioritize an auditing schedule as needed to ensure that suppliers are audited for quality system controls and quality standards. + Collect, catalog, organize and respond to suppliers' documentation regarding Material Compliance. + Developing and providing appropriate training to associates on regulatory and compliance topics, such as REACH, RoHs, Prop 65. + Subject matter expert on material compliance regulations and best practices in the medical device industry, providing thought leadership and guidance to the organization. + Lead initiatives to source and engage reliable suppliers and vendors for additional supply sources and support supplier qualification activities. + Support supplier selection and qualification activities for NPI and Pre-market supplier quality to ensure that issues and complaints related to material problems are reviewed and addressed with the supplier. **Education/Experience:** + Bachelor's degree preferred, or equivalent work experience with a proven track record of success. + Minimum of 5 years’ experience working in a regulated industry, such as medical devices or aerospace. + Experience with material compliance requirements (such as REACH, RoHS, etc.) as well as Medical Device regulations both US and international including applicable ISO standards, EU MDR requirements. + Proficient with Microsoft office software, especially Excel and Word. Computer skilled and able to learn Quality Software Systems. \#INDBH We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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