Director, Quality and Compliance

Responsibilitiesarrow_right

* 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 Stage Gate 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.

Qualificationsarrow_right

* 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.