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Medtronic Sr Quality Systems Manager in North Haven, Connecticut

Sr Quality Systems Manager


North Haven, Connecticut, United States

Requisition #:


Post Date:

Jun 10, 2021

Careers that Change Lives

At Medtronic, our commitment to quality begins with our Mission to strive without reserve for the greatest possible reliability and quality in our products and to be the unsurpassed standard of comparison .

The Medtronic Mission and our Quality Policy drive all that we do. By joining us, you will have the opportunity to live this Mission and help us delivering products and therapies that alleviate pain, restore health, and extend life.

A Day in the Life

In this vital role you will be responsible for leading Operations Quality, establishing and maintaining the Quality Strategic Programs and Compliance projects necessary to achieve corporate and site goals, and partnering with Operations to provide the leadership, knowledge, and resources to ensure quality is built into manufacturing processes and in the Culture.

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

  • 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.

  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.

  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.

  • Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.

  • Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.

  • Co-ordinates legal requests in support of government investigations or litigations.

  • Ensures the quality assurance programs and policies are maintained and modified regularly.

  • Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of companys mission globally.

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, and/or engineers focused manufacturing lines support or continuous improvement projects. 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.

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.

Must Have: Minimum Requirements

  • Bachelors degree required

  • 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

  • Progressive leadership experience in medical devices in Quality function.

Nice to Have

  • Experience working on a matrix organization with centralized operations and quality functions

  • Solid proven leadership competencies:

  • Strategic Direction

  • Talent Management Development

  • Enabling a Diverse and Inclusive workplace

  • Decision Making and enabling change

  • Influencing Accountability

  • Ethical Behaviors

  • Desired skills:

  • Analytical Thinking

  • Problem Solving

  • Teamwork

  • Communication

  • Technical Writing

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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

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)

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.