Manager, Customer Quality

Job Title Manager, Customer Quality Job summary Leads the global Customer Quality team responsible for converting field signals into action and sustainment. The role ensures compliant, timely, and effective execution of complaint handling, medical device reporting, field action coordination, post-market surveillance, customer defect tracking and resolution, and sustainment of field quality improvements. Key Responsibilities Under minimal supervision, general direction, and in accordance with applicable government laws, regulations, and ASP policies, procedures, and guidelines, this position shall: - Lead, coach, and develop a team of customer quality professionals and technicians responsible for complaint handling, post-market surveillance, field actions, failure analysis support, and customer defect tracking and resolution. - Manage complaint handling execution, including intake, evaluation, investigation, documentation, closure, and escalation of reportable and non-reportable product complaints. - Oversee high-risk complaint investigations, ensuring appropriate investigation strategy, technical evaluation, root cause analysis, risk assessment, and linkage to issue escalation, CAPA, field action, or product quality improvement activities as required. - Partner with Regulatory Affairs, Medical Affairs, and Quality leadership to support medical device reporting, vigilance evaluations, health authority responses, and inspection readiness. - Coordinate Customer Quality activities related to field actions, including complaint-triggered escalation, field action completion tracking, closure readiness, and objective evidence to support timely completion and sustainment. - Lead post-market surveillance activities within Customer Quality scope, including data analytics, trending, planning support, reporting, and escalation of emerging product quality or patient safety signals. - Own customer defect tracking and resolution operating mechanisms to translate complaint, service, field failure, and customer feedback signals into cross-functional action and sustained product quality improvements. - Develop and maintain customer quality dashboards and reporting to enable data-driven decision making, including complaint performance, investigation aging, PMS trends, field action status, CDT&R, field failure rate, Paynter charts, and sustainment metrics. - Implement scalable operating mechanisms, including standard work, risk-based work tiering, automation, visual management, QMS workshops, Kaizen activities, and structured follow-up to improve efficiency, strengthen compliance, and reduce cost of poor quality. - Ensure compliance with quality system requirements and regulatory expectations for complaint handling, post-market surveillance, medical device reporting support, field action coordination, CAPA linkage, audit readiness, and robust documentation practices. - Collaborate globally and cross-functionally with RAQA, R&D, IT, Operations, Manufacturing, Supplier Quality, and regional teams to ensure clear interfaces, effective handoffs, alignment on quality priorities, and sustained execution of improvement initiatives. Education and Experience Requirements - Bachelor’s degree (or equivalent experience) in Engineering, Quality, Life Sciences, Health Sciences, Nursing, Biology, Chemistry, Public Health, or related technical discipline. - Minimum 6 years of experience in Customer Quality, Product Quality, Complaint Handling, Post-Market Surveillance, Field Actions, CAPA, or related quality function within the medical device industry. - Minimum 2 years of experience leading or supervising professional employees, technical employees, teams, or cross-functional quality workstreams. Role and Competencies Requirements - Demonstrated ability to lead and develop professional and technical teams while driving accountability for quality, timeliness, compliance, and sustained business results. - Strong working knowledge of complaint handling, high-risk complaint investigations, medical device reporting/vigilance support, post-market surveillance, field actions, CAPA, customer quality, and product quality improvement processes. - Ability to apply risk-based thinking, root cause analysis, and problem-solving to customer, field, technical, operational, and compliance quality challenges. - Experience driving process standardization, continuous improvement, scalable operating models, QMS workshops, Kaizen events, standard work deployment, and sustainment of process improvements. - Data-driven mindset with ability to leverage analytics to identify complaint trends, emerging product risks, customer defect signals, field failure patterns, and performance gaps. - Strong communication skills to convey expectations, present quality risks, escalate issues, align cross-functional stakeholders, and guide teams through competing priorities. - Knowledge of 21 CFR Part 820, 21 CFR Part 803, 21 CFR Part 806, ISO 13485, ISO 14971, EU MDR, MDSAP, and applicable global post-market surveillance and vigilance expectations. - Experience in quality systems within medical device, pharmaceutical, life sciences, or other regulated industry. - Experience supporting regulatory compliance inspections and audits related to complaint handling, post-market surveillance, field actions, CAPA, and quality system processes. - Process excellence tools/methodologies (Six Sigma, FBS, root cause analysis, visual management, standard work, etc.). - Good working knowledge of several FBS tools. - Travel: Domestic and International. Fortive Corporation Overview Fortive's essential technology makes the world safer and more productive. We accelerate transformation in high-impact fields like workplace safety, build environments, and healthcare. We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in healthcare sterilization, industrial safety, predictive maintenance, and other mission-critical solutions. We're a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to advanced technologies that help providers focus on exceptional patient care. We are a diverse team 10,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact. At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference. At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone. At Fortive, we believe in growth. We're honest about what's working and what isn't, and we never stop improving and innovating. Fortive: For you, for us, for growth. About Advanced Sterilization Products ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low-temperature hydrogen peroxide sterilization technology.ASP’s mission is to protect patients during their most critical moments. We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP’s products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning. We Are an Equal Opportunity Employer. Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at [email protected]. Bonus or Equity This position is also eligible for bonus as part of the total compensation package. Pay Range The salary range for this position (in local currency) is 114,100.00 - 190,500.00 Is this role subject to ITAR? The essential duties of this position require adherence to U.S. Government export control regulations. Accordingly, candidates must either be U.S. Persons (i.e., U.S. citizens, U.S. lawful permanent residents, or protected individuals as defined by 8 U.S.C. 1324b(a)(3)) or be prepared to collaborate with the company in securing the necessary U.S. government export authorizations. While the company encourages all interested applicants to apply, please be aware that ongoing employment is dependent upon obtaining the appropriate government export authorizations.