Director, Quality and Compliance

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