Director of Quality

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Service & Repair Quality based in the United States.

This is a senior quality leadership opportunity within a global medical technology environment focused on delivering safe, reliable, and innovative healthcare solutions.

• Lead and develop a world-class Service & Repair Quality organization, including talent acquisition, internal talent development, succession planning, and resource optimization to support business growth.
• Provide global leadership for Service & Repair Quality activities across sites in the United States, Germany, and Japan, coordinating regional priorities and ensuring consistent quality standards.
• Promote awareness and understanding of regulatory, quality, and customer requirements throughout Service & Repair operations.
• Ensure quality systems are regularly audited, reviewed, and updated, driving timely implementation of required changes and corrective actions.
• Apply global regulatory and quality requirements to Service & Repair processes, including FDA requirements, GMP, CAPA, ISO 13485, MDD, CMDCAS, and applicable national and international standards.
• Lead quality compliance support during FDA, Notified Body, and other regulatory inspections, ensuring sites are prepared and responsive to regulatory expectations.
• Develop statistically sound sampling plans and use data analysis to identify trends, resolve quality issues, and drive continuous improvement.
• Establish, maintain, and monitor quality objectives, performance indicators, and trend reporting across Service & Repair operations.
• Design and maintain risk management programs that embed risk-based quality processes across relevant Service & Repair activities.
• Identify opportunities for technology investments, capability development, process improvements, and resource optimization that strengthen the quality organization.
• Coordinate regional initiatives involving regulatory requirements, compliance, technology, and operational priorities.
• Build strong partnerships with site leadership, business unit stakeholders, technical teams, and system owners to drive consistent quality practices.
• Communicate significant quality issues, risks, opportunities, and business considerations to senior leadership and relevant stakeholders.
• Promote an ethical, collaborative, inclusive, and accountable working environment aligned with organizational values.
• Ensure adherence to applicable health, safety, environmental, regulatory, and company policies and procedures.

• Bachelor’s degree or equivalent in a scientific or engineering discipline; a Master of Science is preferred.
• At least 10 years of experience in a GMP-related environment within medical device or biotechnology manufacturing, preferably involving serviceable medical devices.
• At least 7 years of experience leading and managing Quality teams at a company or corporate level, ideally within a medical device environment involving service and repair.
• Strong knowledge of global quality systems and regulatory requirements, including 21 CFR Part 820 and ISO 13485.
• Demonstrated experience supporting or participating in FDA, Notified Body, or other regulatory inspections.
• Strong understanding of Quality Management Systems, GMP, CAPA, risk assessments, SOPs, quality control, and quality standards.
• Ability to quickly understand complex technologies, medical applications, technical requirements, and applicable regulations.
• Strong analytical capabilities, including experience using statistical analysis and data-driven approaches to identify quality trends and improve performance.
• Excellent written, verbal, interpersonal, and presentation skills, with the ability to communicate effectively with scientific and technical professionals.
• Proven ability to influence stakeholders across a matrixed organization and build alignment around common quality objectives.
• Strong ethical judgment and confidence escalating quality or compliance issues when competing business priorities arise.
• Demonstrated success training, developing, mentoring, and motivating quality professionals.
• Advanced proficiency with Microsoft Office applications, including Word, Excel, and Access, as well as Adobe Acrobat.
• Comfortable working in a fast-paced environment with limited direction, shifting priorities, and significant organizational complexity.
• Preferred experience with serviceable-device manufacturing quality, Lean or Six Sigma/Black Belt certification, and global matrixed organizations.
• Strong leadership, fact-based decision-making, consulting, compliance management, inclusive leadership, and continuous-improvement capabilities.
• Willingness to travel approximately 30% domestically and internationally and to work onsite as needed, including potentially up to 100% onsite during critical periods.

• Competitive base salary