Ho Chi Minh City, VNM
3 days ago
298870 - Mfg Operations QA Manager
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. **A Day in the Life** **Responsibilities may include the following and other duties may be assigned.** + Leads the manufacturing site toward excellence in product quality, operational performance, and a culture of putting patients first. + Drives the integrated Quality and GOSC strategies to achieve results. + Engages with and influences leaders across multiple teams, including Core Quality, Operating Units (OUs), and GOSC. + Leads the QA function to ensure quality system development and compliance with FDA Quality System Regulation, ISO 13485/8, MDD, CMDR, and other applicable quality requirements. + Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with policies and that the performance and quality of services meet established internal and external standards and guidelines. + Leads audit and inspection preparation, manages the resolution of audit and inspection findings, and liaises with auditing groups and inspectors throughout all stages of the audit process. + Promotes global standardization and best practice sharing to support the company’s mission worldwide. + Develops, evaluates, implements, and maintains technical quality assurance and control systems or reliability systems and standards related to materials, techniques, and company products. + Leads strategic planning within the function to drive continuous improvement and effectiveness of Quality Operations and Quality Systems. + Coordinates activities with external suppliers and consultants to ensure timely delivery. + Serves as CAPA Board Chair to ensure the effectiveness of the CAPA process and to drive the development of systems and processes for identifying, analyzing, correcting, and preventing quality issues. + Acts as Management Representative to ensure the effectiveness and suitability of the Quality Management System. + Represents the Ho Chi Minh site in OU/Enterprise Quality Leaders team meetings; collaborates with peers across sites and Operating Units on global quality initiatives; and works closely with other MDT sites on shared quality concerns. **Job Requirements:** + Bachelor’s degree in Quality Management, Industrial Management, or Engineering. + Minimum 5–7 years of management experience in the pharmaceutical, medical device, or other highly regulated manufacturing industries, including at least 5 years in a Quality Manager role. + Proven leadership with a strong track record in driving organizational and quality system improvements. + Deep knowledge of Quality System Regulations, ISO standards (especially ISO 13485), and medical device industry standards. + Extensive experience in auditing, QMS management, quality operations, and process improvement. + Strong business acumen with solid operational, financial, and project management capabilities. + Hands-on experience in managing projects and leading change initiatives. + Excellent communication, influencing, problem-solving, and decision-making skills. + Strong leadership in developing teams and managing talent effectively. + Proficient in English (both written and spoken). **PEOPLE MANAGEMENT FUNCTIONAL CAREER STREAM:** Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified area. Levels within the management career stream typically have six or more direct reports. The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports. A key responsibility of roles in this career stream is managing people. which includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals. **DIFFERENTIATING FACTORS** **Autonomy:** Manages subordinate supervisors and/or experienced professionals who exercise latitude and independence in assignments. Provides tactical and / or operational leadership and coaching. Receives assignments in task and objective oriented terms. **Organizational Impact:** Establishes operational plans and implements policies and strategies. Decisions impact program schedules, customer satisfaction levels, or allocation of time, material resources, expenditures and funds. May have budget or P&L accountability for a department, function or geography. Strive for continuous improvement and consistency in deliverables. **Innovation and Complexity:** Proposes modifications to functional operating policies and day-to-day processes. Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem. **Communication and Influence:** Communicates with internal and external customers and vendors regarding ongoing operations. Uses information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties. May interact on issues that have externally shared objectives. **Leadership and Talent Management:** Manages a team consisting of supervisors and / or experienced professionals in the Specialist career stream. Leads, directs and reviews the work of a team who exercise latitude and independence in their assignments. Authorizes hiring, firing, promotion and reward within own area. **Required Knowledge and Experience:** Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area. Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience. **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.  **Benefits & Compensation** **Medtronic 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). **About Medtronic** We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here (http://www.medtronic.com) We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. **We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. **We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. **This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will… + **Build** a better future, amplifying your impact on the causes that matter to you and the world + **Grow** a career reflective of your passion and abilities + **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: **Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. **Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. **Better outcomes for our world** . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. **Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) . For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com
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