Quality & Regulatory Affairs Manager

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 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, 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.
• Verify effectiveness of corrective actions.

Manufacturing Quality & Continuous Improvement

• 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 ensure quality is integrated throughout the manufacturing process.
• Promote employee awareness and accountability for quality and regulatory compliance.
• Provide quality-related training and guidance throughout the organization.

Qualifications

Qualifications & Experience

• Bachelor’s degree in quality management, engineering, manufacturing, or a related field preferred; equivalent experience will be 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.
• Strong leadership, organizational, communication, and problem-solving skills.
• Ability to work effectively with employees at all levels of the organization.

Preferred Qualifications

• ASQ Certified Quality Manager (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.

Additional Information

• 401(k) with Company Match
• Competitive Health, Dental and Vision insurance plans
• Paid Vacation, Holidays and Personal Days
• Paid Life Insurance, Employee Assistance Program and Short-Term Disability

All qualified applicants will receive consideration for employment without regard to race, color, gender identity or expression, age, religion, intellectual disability, mental disability, physical disability, including but not limited to blindness, unless it is shown that such disability prevents performance of the work involved, medical condition, handicap, national origin, ancestry, sexual orientation, marital status, domestic partnership status, parental status, military status, veteran or military discharge status, source of income or housing status or any other status protected by applicable law. GF Health Products, Inc. is a drug free workplace.