Quality Systems Program Manager at Medtronic in BILLERICA, Massachusetts

Job Description:

Careers that Change Lives

In this exciting role as a Quality Systems Program Manager, you will have responsibility for managing various aspects of the Quality System and the CAPA Program for a new acquisition. The CAPA Program Manager will have responsibility for managing key/critical CAPAs to ensure rigor, timeliness, functional engagement and communication. This manager will be responsible for managing a sub-set of our CAPA portfolio. The Program Manager must be self-directed with the ability to take initiative and be accountable for results, and must be team oriented with the confidence, maturity and integrity to lead effectively.

Cardiac Ablation Solutions Operating Unit

The Cardiac Ablation Solutions (CAS) Operating Unit offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions.

A Day in the Life

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

• Ability to build and maintain strong working relationships across the organization and with cross-functional partners within a complex technical environment.
• Instills a sense of urgency to ensure goals are met in a timely manner while meeting regulatory, quality, and customer requirements.
• Successfully communicates to all levels of an organization (engineers and senior leadership).
• Ability to apply business judgment and recommend solutions to complex issues.
• Creatively and effectively challenges status quo when developing solutions.
• Demonstrates effective negotiation skills and is able to see and address business implications of decisions.
• Ability to sell ideas and influence directly and indirectly.
• Ability to turn plans into reality through clear team direction and hands-on action.
• Ability to prioritize work activities to ensure critical priorities achieved with highest impact on goals.
• Manages appropriate levels of interface with Regulatory Affairs, Clinical, Quality, Marketing, Operations and Research & Development.
• Interface with 3rd party auditors, such as FDA, to explain CAPAs.
• ISO 13485:2016 and FDA 21 CFR 820 extensive knowledge
• Strong QMS understanding
• Manage and develop a team of Quality Systems professionals. Establish a high-performing team to drive the organizational goals & objectives and instill quality culture.
• Conduct management review with site leadership on a defined frequency. Ensure management is aware of current quality system performance, trends in products/processes, and changes that could impact our quality system.
• Support the development of a proactive and preventive quality systems culture throughout the business.

Must Have: Minimum Requirements

• Bachelor's Degree in Engineering, Science or technical field with 5+ years of work experience in Engineering, Quality, and/or experience in a regulated industry

• OR Advanced Degree in Engineering, Science or technical field with 3+ years of work experience in Engineering, Quality, and/or experience in a regulated industry

Nice to Have

• 4+ years of project management experience in a matrix organization
• Proven leadership and business acumen; performance-driven.
• Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience)
• Strong collaboration and influence skills (build relationships, leverage others, align and work towards shared outcome-based goals, etc.)
• Experience handling ambiguous work direction from various parts of the organization
• Experience in a highly regulated industry, preferable implantable medical devices
• Change agent - willingness and ability to lead and institute change
• Influence management skills: ability to work cooperatively at all levels in matrix environment to build and maintain the positive relationships required to accomplish organizational goals.
• Excellent communication skills and interpersonal/team effectiveness - ability to communicate to various levels of succinctly and accurately.
• Effective decision-making skills -experience balancing decisions and priorities across needs of several functional departments and willingness to make tough and timely decisions in the face of risk and uncertainty.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

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. Learn more about our benefits here .

MIP Eligible: This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

The provided base salary range is used nationally in the United States (except in Puerto Rico and certain CA locations).The rate offered is compliant with federal/local regulations and may vary by experience,certification/education, market conditions, location, etc.