Director, Quality and Compliance (Medical Devices)

Location: Beverly, Massachusetts, United States

Company

hirify.global operates in medical device and component manufacturing as part of the Freudenberg Group.

What you will do

• Implement and maintain a corporate quality strategy aligned with company policies, objectives, and customer expectations.
• Ensure compliance with ISO 13485, 21 CFR Part 820, GMP, GCP, GLP, FDA, and international medical device regulations.
• Lead continuous improvement, risk management, quality metrics, and quality management reviews across business unit sites.
• Oversee supplier quality systems, product development compliance, StageGate processes, change control, complaints, CAPA, recalls, and field actions.
• Ensure readiness for internal, external, regulatory, FDA, ISO, and customer audits.
• Provide strategic leadership, reporting, mentoring, and collaboration with Operations, R&D, Commercial, regulatory, and site quality teams.

Requirements

• University degree in Engineering, Life Sciences, or a related field.
• 15+ years of progressive Quality and/or Regulatory Affairs experience in the medical device industry.
• Experience in medical device and component manufacturing.
• Demonstrated leadership in developing and maintaining ISO 13485- and FDA-compliant quality management systems.
• Knowledge of FDA QSR, EU MDR/MDD, and other international regulatory frameworks.
• Strong communication, strategic, analytical, and leadership skills.

Culture & Benefits

• Full-time employment.
• Equal opportunity employment commitment.
• Focus on diversity and inclusion across the workforce.