Quality & Regulatory Affairs Manager
Company Description
GF Health Products, Inc. is seeking an experienced Quality & Regulatory Affairs Manager to lead and oversee quality assurance, quality engineering, and regulatory compliance within our medical device manufacturing facility located in Fond du lac, WI.
We are looking for a hands-on candidate who enjoys working on the manufacturing floor with strong technical knowledge of medical device quality systems, regulatory requirements, auditing, and manufacturing processes.
To learn more about GF Health Products, Inc., visit our website at www.grahamfield.com.
Job Description
Quality Management System (QMS) and Regulatory Compliance
- * Develop, implement, maintain, and continuously improve the company's Quality Management System.
- Ensure compliance with FDA Quality Management System Regulation (QMSR), ISO 13485:2016, MDSAP and applicable regulatory requirements.
- Establish and maintain quality policies, procedures, work instructions, and documentation.
- Oversee document control, records management, and change control processes.
- Monitor quality performance metrics and identify opportunities for improvement.
- Monitor regulatory changes and assess their impact on company operations.
- Support regulatory submissions, registrations, and customer or regulatory inquiries as applicable.
- Maintain appropriate regulatory documentation and records.
Audits & Corrective Actions
- * Plan and oversee internal, external, cust...
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