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

This Position is the Quality Leader role for a Manufacturing site for Class II implantable spinal and machined medical devices. The role is also the Management Representative for the QMS entity and will be interacting with multiple stakeholders within GOSC, OUs and Enterprise functions. It is an excellent opportunity for Managers and Senior Managers ready to move to the next step and with the experience and competences to lead the quality team and manage Operations Quality and QMS activities at a medium size/complex site. Role will be directly responsible for Compliance/Quality system, Quality Engineering and product release, Transfers/New Products Quality Assurance, and indirectly for Calibration, Microbiology/Sterility Assurance and Supplier Quality. The role will also support other sites in the Caribbean Region as internal supplier.

The role will report to the Caribbean Region Operations Quality leader.

Must Have: Minimum Requirements

• Requires broad management knowledge to lead project teams in one department.
• Typically has mastery level knowledge and skills within a specific technical or professional discipline with broad understanding of other areas within the job function.
• Requires a bachelor's degree (engineering or equivalent) and minimum of 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience.

Nice to Have:

• Experience with metal processing and secondary operations for spinal, brain and ENT medical devices manufacturing.
• Experience with Class II and III Medical Devices Manufacturing, Pre-market and Post-market quality activities.
• Problem Solving and technical leadership – Six Sigma Green or Black belt certified, knowledge in FTQ, DRM, etc.
• Strong leadership competencies for communicating and influencing Senior leaders across the matrix and in different functions (Manufacturing Operations, Supply Chain, Supplier Quality, R&D, Design Quality, Regulatory, OI, CQS, etc.).
• Experience overseeing quality activities and critical deliverables for Product Transfers and New Product Development.
• Experience leading external audits, mainly working with the FDA as Front Room leader or Management Representative.
• Knowledge and Skills in Quality Risk Management and leading quality plans, remediation, and risk reduction programs.
• Experience managing and working with internal suppliers and customers
• Strong strategic mindset and experience developing and deploying strategic programs and quality objectives.
• Strong people management, mentorship and coaching skills for talent development and people inclusion.

Responsibilities may include the following and other duties may be assigned.

• Leads a manufacturing site to excellence in product quality, operational excellence, and a culture of putting patients first.
• Drives the combined Quality and GOSC strategies to deliver results.
• Interacts with and influences leaders across multiple leadership teams (Core Quality, OUs, and GOSC).
• Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
• May develop, evaluate, implement, and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
• Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.

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 large team which would typically consist of both experienced professionals and managers. Turns the department strategy into a commercial reality by developing, communicating and implementing business plans to achieve business results. Receives assignments in objective oriented terms; has latitude to reinterpret objectives.

Organizational Impact: Initiates programs or projects based on identified business and / or tactical needs. Decisions impact projects or operations, affect the deadlines, resources, and funds, and the achievement of organizational objectives. Typically has budget or P&L accountability for a department, function or geography.

Innovation and Complexity: Develops new objectives, new operating policies, products, processes and standards in support of the job function strategy. 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 concerning ongoing operations, programs or processes. Influences across functions and businesses while balancing divergent objectives to gain cooperation of other parties. May interact on issues that have externally divergent objectives.

Leadership and Talent Management: Manages at least one (department, function, geography typically comprised of other People or Program managers and / or supervisors and experienced professionals. Recommends strategies, goals and plans for a group. Authorizes hiring, firing, promotion and reward within own area.

Required Knowledge and Experience: Requires broad management knowledge to lead project teams in one department. Typically has mastery level knowledge and skills within a specific technical or professional discipline with broad understanding of other areas within the job function. 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 7 years of relevant experience with 5+ years of managerial experience, or advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial 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