SeniorFull TimeEN
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.
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.
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).
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
