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.
