Director QA & Regulatory Affairs - Medical Devices (On-Site)

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

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.