Director, Quality and Compliance

Job description

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 compl...