Director, Service & Repair Quality

Jobgether; United States; Hybrid; USD 150,000 - 259,000; Full time

Benefits offered by this job

Long-term incentive program

Retirement benefits (pension plan and

401(k) plan

Job summary

Jobgether in the United States leads a senior quality leadership role within a global medical technology environment, overseeing Service & Repair Quality across international sites in the United States, Germany, and Japan.

You will drive regulatory compliance, risk management, and quality-system effectiveness across service and repair activities, partnering with site leaders and technical teams to raise capabilities and meet customer and regulatory requirements.

Qualifications

• Bachelor’s degree in science or engineering; MS preferred.
• Minimum 10 years GMP environment experience in medical device/biotech.
• 7+ years leading Quality teams in service/repair within medical devices.
• Strong knowledge of 21 CFR Part 820 and ISO 13485.
• Experience supporting FDA/Notified Body inspections.

Responsibilities

• Lead and develop global Service & Repair Quality organization.
• Global leadership for Service & Repair Quality across US, Germany, Japan.
• Promote regulatory and customer requirements awareness in operations.
• Ensure quality systems are audited, updated, and changes implemented.
• Apply FDA, GMP, CAPA, ISO 13485 standards across processes.
• Lead quality compliance during FDA and Notified Body inspections.
• Develop sampling plans and use data analysis to identify trends.
• Establish quality objectives and KPI tracking across operations.
• Design risk management programs across service activities.
• Identify opportunities for technology investments and process improvements.
• Collaborate with site leadership and stakeholders to align quality practices.
• Communicate significant quality issues to senior leadership.
• Foster ethical, inclusive, and accountable work environment.
• Ensure adherence to health, safety, regulatory, and company policies.

Skills

Regulatory compliance

Quality systems

FDA inspections

Data analysis

Leadership

Communication skills

Education

Bachelor's degree in scientific or engineering discipline

Master of Science preferred

Tools

Word

Excel

Access

Adobe Acrobat

Job description

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

The role will lead Service & Repair Quality across multiple international sites, including operations in the United States, Germany, and Japan.

You will drive continuous improvement, regulatory compliance, risk management, and quality-system effectiveness across service and repair activities.

The position combines strategic leadership with hands‑on oversight of critical quality initiatives, inspections, audits, and operational improvements.

You’ll partner with site leaders, business units, technical teams, and quality stakeholders to strengthen capabilities and ensure customer and regulatory requirements are consistently met.

The role also offers significant influence in building a high‑performing quality organization, developing talent, and introducing data‑driven approaches to quality performance.

Approximately 30% travel is expected, with onsite presence increasing during critical operational or business periods.

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.