Location / Work Arrangement This is 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 Sr. Director of Quality Assurance and Regulatory Affairs. Job Description The Sr. Director of Quality Assurance and Regulatory Affairs (QA/RA) will be an influential member of the organization with primary responsibility for the leadership, management, and continued effectiveness of the Mazza Healthcare Quality Management System (QMS). This role is strategically important to the success of our commercialization efforts, regulatory compliance, customer relationships, and one of Mazza Healthcare's greatest sources of competitive differentiation. The Sr. Director of QA/RA will serve as the company's subject matter expert and provide guidance to Executive Management and other departments in areas related to quality, FDA and ISO requirements, regulatory compliance, and documentation supporting domestic and global product commercialization. This individual will have primary responsibility for maintaining compliance with ISO 13485 and applicable FDA requirements and will lead the organization through ISO certification and surveillance audits, customer audits, and other applicable regulatory or quality audits. Working closely with leaders across the company, the Sr. Director of QA/RA will lead efforts to continually improve product quality, strengthen the QMS, and promote a culture of quality and accountability throughout the organization. Continuous improvement and proactive resolution of quality and regulatory matters, in full compliance with applicable regulations and standards, will be an important focus. This position requires an individual who combines strong technical QA/RA expertise with sound business judgment. The successful candidate must understand the commercial objectives of the organization and be capable of developing practical, compliant solutions that support both regulatory requirements and the needs of the business. The Sr. Director of QA/RA will frequently interact directly with customers, manufacturers, suppliers, auditors, and other external parties and must be able to clearly and confidently communicate complex quality and regulatory concepts to both technical and non-technical audiences. The individual must be comfortable leading customer discussions, presenting information, addressing quality and regulatory questions, 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 and is comfortable operating independently with limited day-to-day oversight. As a small, family-owned and operated business, Mazza Healthcare is seeking an individual who maintains an entrepreneurial spirit, demonstrates initiative and accountability, and is willing and able to contribute beyond specifically defined responsibilities when necessary.

Duties / Responsibilities

Lead the development, implementation, maintenance, and overall effectiveness of Mazza Healthcare's Quality Management System (QMS), ensuring continued compliance with ISO 13485, applicable FDA regulations, and other regulatory requirements. Serve as Mazza Healthcare's primary subject matter expert for quality and regulatory matters, providing practical guidance to Executive Management and other departments. Lead ISO certification and surveillance audits, customer audits, internal audits, and other applicable quality or regulatory audits, including preparation, responses, corrective actions, and ongoing audit readiness. Manage the Quality Department, including establishing priorities, developing team members, delegating responsibilities, and ensuring projects and departmental deliverables are completed accurately and on time. Proactively partner with Executive Management, Sales, Operations, and other departments to support new and existing products, customer opportunities, and domestic and international commercialization. Apply sound business judgment to quality and regulatory matters, developing practical solutions that support business objectives while maintaining appropriate compliance. Represent Mazza Healthcare in customer, manufacturer, supplier, and auditor discussions and clearly communicate complex quality and regulatory concepts to both technical and non-technical audiences. Oversee customer complaints, investigations, risk assessments, corrective and preventive actions, and other quality-related issues through timely resolution. Oversee the qualification and ongoing evaluation of manufacturers and suppliers, including Quality Agreements and supplier audits as appropriate. Determine 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 the QMS, quality processes, documentation, and overall organizational culture of quality and accountability. Proactively identify quality and regulatory risks, priorities, and required actions and independently drive matters through completion with limited day-to-day oversight. Desired Qualifications 10+ 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 knowledge and practical experience with

ISO 13485, FDA

medical device regulations, cGMP, and other applicable medical device regulatory requirements. Demonstrated experience managing a medical device QMS and leading ISO, 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 create a culture of 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 fast-paced, entrepreneurial environment and contribute beyond specifically defined responsibilities when necessary. Proficiency with Microsoft Office and ability to travel domestically and internationally as needed.

Pay:

From $100,000.00 per year

Benefits:

401(k) Health insurance Health savings account Life insurance Paid time off Vision insurance

Work Location:

In person