What are the responsibilities and job description for the Supplier Compliance Specialist position at Astrix?
Our client is a medical device manufacturer and is looking for a Supplier Compliance Specialist to join their growing team!
Location: St. Paul, MN
Pay: 80 - 90k
Duties/Responsibilities include but are not limited to:
Location: St. Paul, MN
Pay: 80 - 90k
Duties/Responsibilities include but are not limited to:
- 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 on 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.
- Other duties as assigned.
- Experience managing suppliers/supplier quality
- 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.
- Minimum of 5 years experience working in a regulated industry, such as medical devices or aerospace.
- Bachelor's degree preferred, or equivalent work experience with a proven track record of success.
- Proficient with Microsoft office software, especially Excel and Word. Computer skilled and able to learn Quality Software Systems.
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