Director of Quality Assurance

Health Staffing Group; Minnesota; On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Retirement plan

Paid time off and holidays

Professional development and growth

Leadership team collaboration

Quality strategy impact

Job summary

Health Staffing Group is seeking a Director of Quality Assurance & Regulatory Affairs to provide strategic leadership over the QMS, regulatory affairs, compliance programs, and QA initiatives. You will ensure products and processes meet regulatory requirements while fostering continuous improvement.

You will oversee regulatory submissions, audit readiness, supplier quality, and quality system performance, leading a team of QA/RA professionals and partnering with cross-functional groups to drive

Qualifications

• Bachelor's degree in a relevant field required.
• 7–10 years of progressive QA/RA leadership in the medical device industry.
• Strong knowledge of FDA regulations and ISO 13485.
• Experience with FDA inspections, ISO audits, and 510(k) submissions.
• Excellent leadership, communication, and organizational skills.
• Experience leading cross-functional teams and driving organizational change.

Responsibilities

• Lead and maintain the organization's QMS to ensure compliance with regulations.
• Oversee regulatory affairs activities including submissions and agency communications.
• Ensure compliance with FDA, ISO 13485, and other quality requirements.
• Direct audits of internal, customer, supplier, and regulatory bodies.
• Manage document and change control processes.
• Lead CAPA investigations and verification of corrective actions.
• Present quality metrics to executive leadership.
• Collaborate with Operations, Engineering, Manufacturing, and Supply Chain to drive improvements.
• Promote a culture of quality and continuous improvement.

Skills

Leadership

Communication

Analytical thinking

Problem-solving

Cross-functional leadership

Change management

Education

Bachelor's degree in Engineering/Quality/Regulatory Affairs/Life Sciences or related field

Master's degree (preferred)

Job description

Job Title: Director of Quality Assurance & Regulatory Affairs

Reports To: President

Job Type: Full-Time

Department: Quality Assurance & Regulatory Affairs

About the Role

This role is responsible for providing strategic leadership and oversight of the organization's Quality Management System (QMS), regulatory affairs, compliance programs, and quality assurance initiatives. The Director of Quality Assurance & Regulatory Affairs ensures products, processes, and quality systems comply with applicable regulatory requirements, industry standards, and customer expectations while fostering a culture of continuous improvement.

Working closely with executive leadership and cross-functional teams, this position oversees regulatory submissions, quality system performance, supplier quality, customer complaint management, and audit readiness. The ideal candidate is a collaborative leader with extensive experience in medical device quality systems, regulatory compliance, and operational excellence.

Key Responsibilities

• Lead and maintain the organization's Quality Management System (QMS) to ensure compliance with applicable regulations and quality standards.
• Oversee regulatory affairs activities, including regulatory submissions, product registrations, and agency communications.
• Ensure compliance with FDA regulations, ISO 13485, and other applicable quality and regulatory requirements.
• Direct internal, customer, supplier, and regulatory audits while ensuring timely resolution of findings.
• Manage document control and change control processes to maintain compliance and operational efficiency.
• Lead the Corrective and Preventive Action (CAPA) program, ensuring effective investigation, implementation, and verification of corrective actions.
• Facilitate Management Review meetings and present quality system performance metrics to executive leadership.
• Oversee supplier qualification, supplier performance monitoring, and supplier quality audits.
• Manage customer complaint investigations, trending, and regulatory reporting requirements.
• Develop, monitor, and communicate key quality performance indicators and organizational quality objectives.
• Lead, mentor, and develop the Quality Assurance and Regulatory Affairs team.
• Partner with Operations, Engineering, Manufacturing, and Supply Chain to drive quality improvements, risk reduction, and continuous process optimization.
• Promote a culture of quality, compliance, and continuous improvement throughout the organization.

Qualifications

Required

• Bachelor's degree in Engineering, Quality, Regulatory Affairs, Life Sciences, or a related field.
• Minimum of 7–10 years of progressive leadership experience in Quality Assurance and Regulatory Affairs within the medical device industry.
• Strong knowledge of FDA regulations, ISO 13485, and medical device quality system requirements.
• Experience managing FDA inspections, ISO certification audits, and regulatory compliance programs.
• Experience with 510(k) submissions and medical device regulatory processes.
• Proven leadership, communication, and organizational skills.
• Strong analytical and problem-solving abilities.
• Experience leading cross-functional teams and driving organizational change.

Preferred

• Master's degree in Engineering, Business Administration, Regulatory Affairs, or a related discipline.
• Professional certifications such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), RAC, or equivalent.
• Experience with supplier quality management and risk management methodologies.
• Knowledge of global regulatory requirements and international quality standards.
• Experience implementing continuous improvement initiatives within regulated manufacturing environments.

What We Offer

• Comprehensive medical, dental, and vision benefits.
• Employer-sponsored retirement savings plan.
• Paid time off and company holidays.
• Professional development and leadership growth opportunities.
• Collaborative leadership team focused on innovation, quality, and operational excellence.
• Opportunity to shape organizational quality strategy and drive continuous improvement across the business.