Specialist, Quality Assurance & Regulatory Affairs (QA/RA) (Lincolnshire)

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 Specialist, Quality Assurance and Regulatory Affairs (QA/RA) to support our expanding product portfolio and quality operations.

Job Description

The Specialist, Quality Assurance and Regulatory Affairs (QA/RA) will play an important role in supporting the daily execution, maintenance, and continuous improvement of Mazza Healthcare's Quality Management System (QMS). This position will be responsible for a broad range of tactical quality assurance and regulatory activities, ensuring that products, documentation, and internal processes comply with ISO 13485, applicable FDA regulations, and customer requirements.

Working closely with the Sr. Director of QA/RA and other departments, the QA/RA Specialist will support incoming product inspections, quality documentation, product specification development, private label artwork and labeling compliance, customer complaints, supplier qualifications, and internal and external audit preparation.

This individual will also support Mazza Healthcare's growing private label business by coordinating product documentation, labeling, and regulatory requirements associated with new product introductions, customer requests, and ongoing product maintenance.

The successful candidate will be highly organized, detail-oriented, and comfortable managing multiple projects and priorities simultaneously. Strong attention to detail, documentation accuracy, and the ability to independently follow established procedures and drive assigned tasks through completion will be essential.

As a small, family-owned and operated business, Mazza Healthcare is seeking a motivated and adaptable individual who demonstrates initiative, accountability, and a willingness to contribute across a variety of quality, regulatory, and operational activities. This position provides an opportunity to gain broad exposure to the healthcare industry and contribute directly to the continued growth and success of the organization.

Duties / Responsibilities

• Support the daily execution and maintenance of Mazza Healthcare's Quality Management System (QMS), ensuring compliance with ISO 13485, applicable FDA regulations, and internal procedures.
• Review incoming product inspection reports and supporting documentation to verify compliance with established product specifications and quality requirements.
• Develop, maintain, and update product-specific Quality Plans, inspection forms, SOPs, work instructions, and other controlled quality documents.
• Create, review, and maintain product specifications, technical documentation, and supporting regulatory records for new and existing products.
• Coordinate the development, review, and approval of private label artwork and product labeling, ensuring compliance with applicable FDA regulations, customer requirements, and internal quality standards.
• Assist with internal audits, ISO certification/surveillance audits, customer audits, and other regulatory assessments, including preparation, documentation, and follow-up activities.
• Support customer complaint investigations, nonconforming product evaluations, corrective and preventive actions (CAPAs), and other quality-related matters.
• Assist with supplier qualification and ongoing monitoring activities, including collection and review of certifications, Quality Agreements, and other compliance documentation.
• Respond to customer and supplier quality/regulatory inquiries, including documentation requests, material compliance information, and customer portal submissions.
• Maintain accurate and organized quality records, regulatory documentation, and product information within internal databases and shared systems.
• Collaborate with Sales, Operations, manufacturers, and suppliers to support customer requirements, new business opportunities, and ongoing product maintenance.
• Proactively manage assigned quality and regulatory projects, ensuring timely completion of deliverables while identifying opportunities for process improvement.

Desired Qualifications

• Bachelor's degree in Quality Assurance, Regulatory Affairs, Life Sciences, Biomedical Sciences, Engineering, Healthcare, or a related field preferred. Equivalent relevant industry experience will also be considered.
• ~3 years of experience in Quality Assurance, Regulatory Affairs, Quality Control, or a related function, preferably within the healthcare industry.
• Working knowledge of ISO 13485, FDA medical device regulations, cGMP, and applicable healthcare quality and regulatory requirements.
• Experience working within a documented Quality Management System, including SOPs, quality records, document control, and compliance activities.
• Experience reviewing product inspection documentation, developing quality plans or inspection forms, and maintaining product quality records.
• Experience creating, reviewing, or maintaining product specifications, technical documentation, and/or regulatory records.
• Familiarity with FDA medical device labeling requirements, including product identification, UDI requirements, private label artwork development, and packaging compliance preferred.
• Experience supporting internal, external, customer, or ISO audits, including audit preparation and documentation management.
• Familiarity with customer complaint handling, nonconforming product investigations, CAPAs, and supplier qualification processes.
• Proficiency with Microsoft Office, including Word, Excel, Outlook, and PowerPoint.
• Experience with Microsoft Access databases, including data entry, reporting, queries, and database maintenance, strongly preferred.
• Experience with Adobe Illustrator, Acrobat, or similar artwork/design software is a plus.
• Strong organizational skills, exceptional attention to detail, and the ability to maintain accurate and complete documentation.
• Excellent written and verbal communication skills, with the ability to interact professionally with customers, manufacturers, suppliers, and internal team members.
• Highly self-motivated and capable of independently managing multiple assignments, meeting deadlines, and following tasks through completion.
• Ability to operate effectively in a fast-paced, entrepreneurial environment and contribute beyond specifically defined responsibilities when necessary.

Compensation & Benefits

This is a full-time, salaried position with an opportunity for an annual performance-based bonus.

Mazza Healthcare offers a comprehensive employee benefits package, including medical, dental, and vision insurance, paid time off, paid holidays, and a 401(k)-retirement plan with a company Safe Harbor contribution. Compensation will be commensurate with experience and qualifications.