Quality & Regulatory Affairs Manager

Basic American Medical Products•Fond du Lac, WI

4h•Onsite

About The Position

GF Health Products, Inc. is seeking a hands-on Quality & Regulatory Affairs Manager to lead and oversee quality assurance, quality engineering, and regulatory compliance at its medical device manufacturing facility in Fond du Lac, Wisconsin. The role requires strong technical knowledge of medical device quality systems, regulatory requirements, auditing, and manufacturing processes. The manager is responsible for developing, implementing, maintaining, and continuously improving the company’s Quality Management System (QMS), and ensuring compliance with FDA QMSR, ISO 13485:2016, MDSAP, and other applicable requirements. The role oversees quality audits, investigations and corrective actions, manufacturing quality and continuous improvement, supplier controls, and quality personnel. The manager also works across the organization to promote quality and regulatory compliance throughout manufacturing.

Requirements

At least 5 years of quality experience in a regulated manufacturing environment; medical device manufacturing is preferred.
Working knowledge of FDA QMSR, ISO 13485:2016, MDSAP, and applicable quality system requirements.
Experience managing audits, CAPA, nonconformance investigations, and root cause analysis.
Experience with process validation, supplier quality, and manufacturing quality systems.
Strong leadership, organizational, communication, and problem-solving skills.
Ability to work effectively with employees at all levels of the organization.
Bachelor’s degree in quality management, engineering, manufacturing, or a related field preferred; equivalent experience will be considered.

Nice To Haves

Medical device manufacturing experience.
ASQ Certified Quality Manager credential (CQE, CQA, or CMQ/OE).
Lead auditor training or certification in ISO 13485.
Experience with FDA inspections and regulatory agency interactions.
Experience implementing or improving a Quality Management System.

Responsibilities

Develop, implement, maintain, and continuously improve the company’s Quality Management System.
Ensure compliance with FDA 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.
Plan and oversee internal, external, customer, and regulatory audits.
Serve as the primary contact for quality-related customer and regulatory audits.
Lead investigations, nonconformance reviews, root cause analysis, and corrective and preventive actions (CAPA).
Ensure timely and effective resolution of audit findings and quality issues, and verify corrective-action effectiveness.
Oversee incoming, in-process, and final inspection activities.
Work with manufacturing and engineering to resolve quality issues and improve production processes.
Review and analyze scrap, rework, customer complaints, and other quality performance indicators.
Lead initiatives to reduce defects, improve product reliability, and prevent recurrence of quality issues.
Support validation and qualification activities, including equipment, processes, and production methods.
Ensure appropriate controls are in place for suppliers and outsourced processes.
Provide leadership, direction, and development for quality personnel.
Establish departmental goals and performance expectations.
Collaborate with cross-functional teams to integrate quality throughout manufacturing.
Promote employee awareness and accountability for quality and regulatory compliance.
Provide quality-related training and guidance throughout the organization.