Sr. Operations Quality Director

Job description

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the LifeResponsibilities Responsibilities may include the following and other duties may be assigned: 1. Lead manufacturing quality across Asia manufacturing sites, including Singapore, Malaysia, Vietnam, Shanghai, and other China locations, ensuring the highest standards of product quality, patient safety, regulatory compliance, and operational excellence. 2. Drive the regional Quality strategy in partnership with Global Operations & Supply Chain (GOSC) leaders to deliver business objectives, quality performance, and continuous improvement initiatives across multiple manufacturing sites. 3. Partner and influence senior leaders across Quality, Operations, Engineering, Supply Chain, and Business Units to strengthen quality culture and achieve strategic goals. 4. Provide leadership and oversight for quality management systems, processes, programs, and procedures to ensure compliance with corporate policies, regulatory requirements, and international quality standards. 5. Assess manufacturing site quality and operational performance, identify risks and opportunities, and drive sustainable improvements in product quality, process capability, and operational effectiveness. 6. Rapidly engage with site leadership teams to evaluate and advance ongoing quality initiatives, ensuring alignment, execution excellence, and measurable outcomes across the region. 7. Lead FDA and regulatory inspection readiness activities, including preparation, audit management, inspection support, remediation planning, and sustained compliance across manufacturing sites. 8. Develop and maintain robust quality assurance, quality control, and reliability systems related to manufacturing processes, materials, products, and production technologies. 9. Evaluate organizational capability, assess talent and succession risks, and build strong quality leadership pipelines across the Asia region through coaching, development, and talent planning. 10. Facilitate the sharing of quality best practices, lessons learned, and operational excellence initiatives across manufacturing sites to drive consistency and continuous improvement. 11. Direct cross-functional collaboration with external suppliers, regulatory agencies, consultants, and business partners to ensure timely execution of quality-related initiatives and compliance requirements. 12. Foster a culture of accountability, patient focus, quality excellence, and continuous improvement while developing high-performing teams across a diverse and geographically dispersed organization. Required Qualifications & Experience • Bachelor's degree in Engineering, Life Sciences, Quality, Manufacturing, or a related discipline. • Minimum of 15 years of relevant experience, including 10+ years of managerial and people leadership experience. • Experience leading quality functions within a regulated manufacturing environment. • Strong understanding of quality management systems, regulatory compliance, risk management, auditing, and continuous improvement methodologies. • Experience supporting regulatory inspections and audit readiness activities, including FDA inspections and remediation programs. • Proven ability to lead cross-functional teams and influence stakeholders across Quality, Operations, Engineering, Supply Chain, and Business functions. • Demonstrated success in building, developing, and leading high-performing teams. Preferred Qualifications • Prior site quality leadership experience. • Experience leading quality across multiple manufacturing sites, geographies, or regions. • Experience within the medical device, pharmaceutical, biotechnology, or other highly regulated industries. • Experience assessing organizational capability, succession planning, and talent development across multiple locations. • Demonstrated ability to drive quality culture transformation and operational excellence initiatives. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com. ‌ Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). This position is eligible for an annual long-term incentive plan.