Hands-On Quality & Regulatory 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

Competitive Health, Dental and Vision

Paid Vacation, Holidays and Personal D

Paid Life Insurance, EAP and Short‑/or

Job summary

GF Health Products, Inc. is seeking an experienced Quality & Regulatory Affairs Manager to lead quality assurance, quality engineering, and regulatory compliance within our Fond du Lac, WI manufacturing facility.

This hands-on role requires strong technical knowledge of medical device quality systems, regulatory requirements, auditing, and manufacturing processes. The ideal candidate will develop and maintain the QMS, monitor regulatory changes, and support submissions and regulatory inquiries.

Qualifications

• Bachelor’s degree in quality management, engineering, manufacturing or related field preferred; equivalent experience considered.
• 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.

Responsibilities

• Develop, implement, maintain, and continuously improve the Quality Management System (QMS).
• Ensure compliance with FDA QMSR, ISO 13485:2016, MDSAP, and regulatory requirements.
• Lead audits (internal, external, customer, regulatory) and CAPA activities.
• Oversee document control, records management, and change control processes.
• Collaborate with manufacturing and engineering to resolve quality issues and improve production processes.

Skills

Quality management

Regulatory affairs

Auditing

CAPA

Leadership

Education

Bachelor's degree in quality management, engineering, manufacturing

Job description

GF Health Products, Inc. is seeking an experienced Quality & Regulatory Affairs Manager to lead quality assurance, quality engineering, and regulatory compliance within our Fond du Lac, WI manufacturing facility.

This hands-on role requires strong technical knowledge of medical device quality systems, regulatory requirements, auditing, and manufacturing processes. The ideal candidate will develop and maintain the QMS, monitor regulatory changes, and support submissions and regulatory inquiries.