Director, Quality and Compliance

Freudenberg Group • Beverly, MA

8d

About The Position

Working at Freudenberg: We will wow your world! Responsibilities: Leadership: 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. Compliance: Oversee key quality projects, strategies, and customer quality initiatives. Ensure compliance with all internal corporate Quality policies and procedures. Provide guidance and oversight into product development and ensure compliance to StageGate processes for the business. Ensure timely input for product and Quality System change control activities. Maintain current knowledge of medical device regulations and ensure compliance with new and evolving requirements. Assist site Quality leadership in managing relationships with regulatory agencies, notified bodies, and distributors globally. Audit & Compliance: Ensure business unit readiness for internal, external, and regulatory audits. 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. Oversee critical product complaints, recalls and field actions, and agency notifications, as required. Lead risk management and compliance reviews across SBU sites. Leadership & Collaboration: Provide strategic leadership to Quality and compliance teams across the business. Partner with Operations, R&D, and Commercial teams to align compliance with business objectives. Drive accountability for compliance metrics and ensure transparency in reporting to executive leadership. Mentor and develop regulatory and quality leaders across business unit. 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. The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law. Freudenberg Medical LLC Welcome to Freudenberg Without Freudenberg, indoor air would not be as clean, cars would not drive and wounds would not heal as quickly. And these are just three examples from thousands of our applications. Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.

Requirements

• 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.
• Oversee key quality projects, strategies, and customer quality initiatives.
• Ensure compliance with all internal corporate Quality policies and procedures.
• Provide guidance and oversight into product development and ensure compliance to StageGate processes for the business.
• Ensure timely input for product and Quality System change control activities.
• Maintain current knowledge of medical device regulations and ensure compliance with new and evolving requirements.
• Assist site Quality leadership in managing relationships with regulatory agencies, notified bodies, and distributors globally.
• Ensure business unit readiness for internal, external, and regulatory audits.
• 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.
• Oversee critical product complaints, recalls and field actions, and agency notifications, as required.
• Lead risk management and compliance reviews across SBU sites.
• Provide strategic leadership to Quality and compliance teams across the business.
• Partner with Operations, R&D, and Commercial teams to align compliance with business objectives.
• Drive accountability for compliance metrics and ensure transparency in reporting to executive leadership.
• Mentor and develop regulatory and quality leaders across business unit.

What This Job Offers

• Job Type: Full-time
• Career Level: Director