Director, Quality Assurance & Regulatory Affairs (QA/RA)

Mazza Healthcare; Lincolnshire (IL); On-site; USD 150,000 - 230,000; Full time

Benefits offered by this job

Performance bonus

Health insurance

401(k) retirement plan with Safe Harbo

Job summary

Mazza Healthcare in Lincolnshire, IL is seeking a Director of Quality Assurance and Regulatory Affairs to lead the Quality Management System and ensure ISO 13485 and FDA compliance for domestic and international product commercialization.

You will interact with customers, manufacturers, suppliers, and auditors, lead audits and CAPA processes, drive continuous improvement, and communicate complex QA/RA concepts to diverse audiences.

Qualifications

• 7+ years in Quality Assurance, Regulatory Affairs, or QMS leadership in medical devices
• Experience leading ISO certification, surveillance audits, and customer/regulatory audits
• Strong knowledge of ISO 13485 and FDA medical device regulations
• Demonstrated ability to balance quality/regulatory requirements with business goals
• Excellent written and verbal communication, and ability to interact with customers, suppliers, and auditors
• Willingness to travel domestically and internationally
• In-office leadership role based at Mazza Healthcare HQ in Lincolnshire, IL

Responsibilities

• Maintain and improve Mazza Healthcare's QMS to ISO 13485 and FDA standards
• Lead regulatory affairs and quality oversight for domestic and international product commercialization
• Coordinate ISO certification and surveillance audits, customer audits, and corrective actions
• Manage Quality Department priorities, deliverables, and cross-functional collaboration
• Interact with customers, manufacturers, suppliers, and auditors to convey complex QA/RA concepts
• Drive continuous improvement of quality processes, documentation, and product specifications
• Oversee supplier qualifications and Quality Agreements; manage CAPA and risk assessments

Skills

Leadership

ISO 13485

FDA medical device regulations

QMS management

Regulatory audits

CAPA and risk management

Communication/presentation

Travel (domestic/international)

Tools

Microsoft Office

Job description

This is primarily an in-office position based at Mazza Healthcare's corporate headquarters in Lincolnshire, Illinois. Regular in-person presence is expected given the leadership and cross-functional responsibilities of the role.

Company Description

Mazza Healthcare is a healthcare solutions company with strong expertise in global sourcing and private label portfolio development. We advance the cost-effectiveness and quality of healthcare products while remaining committed to patient safety. Mazza Healthcare has experienced rapid growth over the past several years and is currently seeking a Director of Quality Assurance and Regulatory Affairs.

Job Description

The Director of Quality Assurance and Regulatory Affairs (QA/RA) will play a key leadership role in the management, maintenance, and continued effectiveness of Mazza Healthcare's Quality Management System (QMS). This position is strategically important to the success of our commercialization efforts, regulatory compliance, customer relationships, and commitment to product quality and patient safety.

The Director of QA/RA will serve as a subject matter expert in quality and regulatory affairs, providing guidance to the business regarding ISO 13485, FDA requirements, regulatory compliance, and documentation supporting domestic and international product commercialization. This individual will have significant responsibility for maintaining the QMS, supporting organizational compliance, and coordinating ISO certification and surveillance audits, customer audits, and other applicable quality and regulatory activities.

Working closely with Management and departmental leaders, the Director of QA/RA will help drive continuous improvement, strengthen internal quality processes, and promote a culture of quality and accountability throughout the organization. The position requires an individual who combines strong technical QA/RA expertise with sound business judgment and the ability to develop practical, compliant solutions that support broader business objectives.

The Director of QA/RA will interact directly with customers, manufacturers, suppliers, and auditors and must be capable of clearly communicating complex quality and regulatory concepts to both technical and non-technical audiences. The successful candidate must be comfortable leading customer discussions, presenting information, and representing Mazza Healthcare professionally in external meetings.

This role is ideally suited to a highly motivated, detail-oriented self-starter who takes ownership of responsibilities, manages competing priorities, and drives initiatives through completion with limited day-to-day oversight.

Duties / Responsibilities

• Support the development, implementation, maintenance, and continual improvement of Mazza Healthcare's Quality Management System (QMS), ensuring compliance with ISO 13485, applicable FDA regulations, and other regulatory requirements.
• Serve as a key subject matter expert for quality and regulatory matters, providing practical guidance to Executive Management and other departments.
• Support and coordinate ISO certification and surveillance audits, including preparation, execution, and corrective actions.
• Coordinate Quality Department activities, including managing priorities, supporting team members, and ensuring timely completion of assigned deliverables.
• Partner with Executive Management, Sales, Sourcing, and Operations to support new and existing products, customer opportunities, and domestic and international commercialization.
• Represent Mazza Healthcare in customer, manufacturer, supplier, and auditor discussions, clearly communicating complex quality and regulatory concepts.
• Oversee customer complaints, investigations, risk assessments, corrective and preventive actions (CAPA), and other quality-related matters through timely resolution.
• Support the qualification, evaluation, and ongoing management of manufacturers and suppliers, including Quality Agreements and supplier audits as appropriate.
• Evaluate regulatory and QMS requirements associated with new products, suppliers, processes, and business opportunities and ensure appropriate actions are implemented.
• Ensure compliance with applicable customer, federal, state, and international quality and regulatory requirements.
• Drive continuous improvement of quality processes, product specifications, documentation, and overall organizational effectiveness.
• Proactively identify quality and regulatory risks, establish priorities, and independently drive initiatives and outstanding matters through completion.

Desired Qualifications

• 7+ years of Quality Assurance, Regulatory Affairs, and/or Quality Management System experience, including demonstrated leadership experience.
• Minimum of 5 years of experience within the medical device industry.
• Strong demonstrated knowledge and practical experience with ISO 13485, FDA medical device regulations, cGMP, and other applicable regulatory requirements.
• Demonstrated experience managing or co-leading a medical device QMS and leading ISO certification, surveillance, customer, and/or regulatory audits.
• Strong business acumen with the ability to balance quality and regulatory requirements with practical business objectives.
• Proven leadership and management skills with the ability to establish priorities, develop employees, delegate effectively, and promote accountability and ownership.
• Highly self-motivated, detail-oriented, and capable of independently managing multiple priorities and driving matters through completion with limited oversight.
• Excellent written, verbal, and presentation skills with the ability to clearly communicate complex concepts and confidently represent Mazza Healthcare with customers, manufacturers, suppliers, and auditors.
• Ability to operate effectively in a dynamic, entrepreneurial environment and contribute beyond specifically defined responsibilities when necessary.
• Proficiency with Microsoft Office, including Word, Excel, Access, and PowerPoint.
• Ability to travel domestically and internationally as needed.

This is a salaried position with the opportunity to earn an annual performance-based bonus. Mazza Healthcare also offers employees a comprehensive benefits package, including health insurance and a 401(k) retirement plan with a Safe Harbor employer contribution.