Qualifications

• University degree in Engineering, Life Sciences, or a related field.
• 15+ years of experience in Quality and/or Regulatory Affairs within the medical device industry.
• Experience in medical device and component manufacturing.
• Proven leadership in ISO 13485- and FDA-compliant QMS systems development and maintenance.
• In-depth knowledge of FDA QSR, EU MDR/MDD, and global regulatory frameworks.
• Strong strategic, analytical, and leadership communication skills.

Responsibilities

• Implement and uphold a Corporate quality strategy aligned with policies and customer expectations.
• Ensure compliance with standards such as ISO 13485 and FDA regulations throughout operations.
• Lead continuous improvement initiatives to boost product quality and process efficiency.
• Oversee supplier quality systems and key quality metrics for accountability.
• Develop and support the implementation of Corporate Quality standards.
• Coordinate Quality Management Reviews across business units and sites.
• Guide product development to ensure adherence to Quality System processes.

Benefits

• Commitment to diversity and inclusion in the workplace.
• Opportunities for professional development and leadership mentoring.
• Strong emphasis on compliance and high-quality standards in a reputable company.
• Supportive collaboration with cross-functional teams in a dynamic environment.
• Engagement in continuous improvement initiatives to enhance personal and team performance.