Director of Quality Operations(m/w/x)

# Director of Quality Operations (m/f/d) * Hechingen * Qualitätsmanagement, Qualitätssicherung * Publiziert: 15.04.2025 !scheme image We are hiring a **Director of Quality Operations  (m/f/d)** ## Your Strength * 10+ years of experience in quality management in a manufacturing organization within the medical industry * Extensive knowledge of FDA regulations, ISO 13485, and other relevant quality standards * Proven leadership experience in quality control, manufacturing quality, supplier quality, and process validation * Strong analytical, problem-solving, and decision-making abilities * Excellent communication, interpersonal, and team leadership skills * Experience in managing audits, regulatory inspections, and compliance initiatives ## Your Contribution * Oversee manufacturing control, quality control, and quality control laboratory operations to ensure compliance with FDA, ISO, and other applicable regulations * Release of products to the markets * Lead qualification of equipment, verification and validation of processes, and change control activities * Ensure robust product lifecycle management * Establish and monitor key performance indicators * Lead change control for sustaining business * Develop and mentor the sustain quality team, fostering a culture of quality awareness and operational excellence * Collaborate cross-functionally * Serve as the primary point of contact  for quality-related communications with internal stakeholders, regulatory authorities, and external customers ## Our Strength * An exciting field of activity in a global team * An independent area of responsibility * Intensive training with mentoring program * Various benefits such as hybrid working, business bike, company pension and subsidy for our canteen