Director, Service & Repair Quality

Accountabilities:

• • 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.

  Requirements:

  • 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.

  Benefits:

  • Competitive base salary range of $150,000–$258,750 annually, with actual compensation determined by factors such as experience, qualifications, and location.
  • Eligibility to participate in a long-term incentive program, subject to applicable plan terms.
  • Retirement benefits including a pension plan and 401(k) savings plan.
  • 120 hours of vacation per calendar year, subject to applicable policies and date of hire.
  • Paid sick time, including applicable state-specific provisions.
  • 13 paid holidays, including floating holidays, per calendar year.
  • Up to 40 hours of Work, Personal and Family Time per calendar year.
  • Up to 480 hours of parental leave within one year of the birth, adoption, or foster care of a child.
  • Bereavement, caregiver, volunteer, and military-spouse leave programs, subject to applicable policies.
  • Opportunity to work within a global medical technology environment focused on improving patient outcomes.
  • International exposure and collaboration across multidisciplinary and geographically distributed teams.
  • Leadership, talent development, and continuous-improvement opportunities within a complex global quality organization.
  • Hybrid and remote work options may be considered depending on location and business needs; onsite attendance may increase during critical periods.