Senior Quality & Regulatory Affairs Leader - Medical Devices

Basic American Medical Products™; Fond du Lac (WI); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

401(k) with Company Match

Health, Dental and Vision insurance

Paid Vacation, Holidays and Personal</

Short-Term Disability

Job summary

GF Health Products, Inc. in Fond du Lac, WI seeks an experienced Quality & Regulatory Affairs Manager to lead QA, quality engineering, and regulatory compliance in our medical device manufacturing facility.

The role centers on developing and maintaining the Quality Management System (QMS) and ensuring compliance with FDA QMSR, ISO 13485:2016, MDSAP, and regulatory requirements. You will drive audits, CAPA, continuous improvement, supplier quality, and cross-functional collaboration to deliver

Qualifications

• Bachelor’s degree in quality management, engineering, manufacturing, or related field.
• Minimum of 5 years of quality experience in a regulated manufacturing environment, preferably medical device manufacturing.
• 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.

Responsibilities

• Develop, implement, maintain, and continuously improve the 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.

Skills

Quality Management

Regulatory Compliance

Audits & CAPA

Leadership

Cross-functional Collaboration

Education

Bachelor’s degree in quality management or related field

Job description

GF Health Products, Inc. in Fond du Lac, WI seeks an experienced Quality & Regulatory Affairs Manager to lead QA, quality engineering, and regulatory compliance in our medical device manufacturing facility.

The role centers on developing and maintaining the Quality Management System (QMS) and ensuring compliance with FDA QMSR, ISO 13485:2016, MDSAP, and regulatory requirements. You will drive audits, CAPA, continuous improvement, supplier quality, and cross-functional collaboration to deliver