Global Head of Quality & Compliance — Medical Devices

Freudenberg Medical LLC; Beverly (MA); On-site; USD 180,000 - 260,000; Full time

Job summary

Freudenberg Medical LLC is seeking a senior quality and regulatory leader to implement and maintain a corporate quality strategy aligned with policies, customer expectations, and global regulatory requirements across sites.

You will oversee supplier quality, lead audits with FDA and notified bodies, drive continuous improvement, and mentor teams to ensure ISO 13485 and FDA QSR compliance while advancing product quality and process efficiency.

Qualifications

• University degree in Engineering, Life Sciences, or related field.
• 15+ years of progressive experience in Quality and/or Regulatory Affairs within the medical device industry.
• Proven experience in medical device and component manufacturing.
• Demonstrated leadership in developing and maintaining ISO 13485- and FDA-compliant QMS systems.
• Knowledge of FDA QSR, EU MDR/MDD, and other international regulatory frameworks.
• Effective communicator with strong strategic, analytical, and leadership skills.

Responsibilities

• 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, and GLP across all operations.
• Lead continuous improvement initiatives across sites to enhance product quality, compliance, and process efficiency.
• Oversee supplier quality systems, quality management reviews, and quality metrics (KPIs).
• Champion a culture of quality, accountability, and compliance across the Freudenberg Medical business.
• Develop and support the implementation of Corporate Quality standards and ensure compliance.
• Coordinate Quality Management Review with business units and sites.
• Audit & Compliance: Oversee the complaint and CAPA processes and verify timely closure of findings.
• Act as Quality business unit representative during FDA, ISO, and customer audits.
• Collaborate with the site Quality Leaders and Management Representatives to ensure audit schedules and procedures meet business expectations.

Skills

Quality leadership

Regulatory affairs

Quality systems

Strategic leadership

Communication

15+ years exp

Education

University degree in Engineering/Life Sciences/related field

Job description

Freudenberg Medical LLC is seeking a senior quality and regulatory leader to implement and maintain a corporate quality strategy aligned with policies, customer expectations, and global regulatory requirements across sites.

You will oversee supplier quality, lead audits with FDA and notified bodies, drive continuous improvement, and mentor teams to ensure ISO 13485 and FDA QSR compliance while advancing product quality and process efficiency.