Principal Quality Systems Specialist

Careers that Change Lives
A career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health, and extend life for millions of people worldwide.
In this exciting role as a Principal Quality Systems Specialist, you will manage assigned projects and work with other stakeholders to achieve desired results within the Quality Systems.
The Cranial and Spinal Technologies Organization (CST) develops life-restoring therapies and healthcare solutions that span the care continuum, integrating technologies and applying clinical and economic evidence to increase patient access, improve the efficiency of procedures, and deliver successful patient outcomes.
Within CST, this role will support Spine and biologics, which offers procedural solutions for spine surgery and bone grafting solutions for spinal fusion.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.

• Provides oversight for developing and maintaining 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 analysis oversight, continuing 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.
• Coordinates 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 company's mission globally.
• Ensuring QMS requirements and processes are established and maintained
• Conducting management reviews and reporting QMS performance and effectiveness, including any need for improvement, to Management with Executive Responsibility
• Ensuring the promotion of awareness of applicable regulatory, customer, and QMS requirements throughout their organization.
• Travel requirement: less than 25%

Must Have: Minimum Requirements

• Bachelors degree required
• Minimum of 7 years of quality system experience or advanced degree with a minimum of 5 years experience

Nice to Have

• Audit - Quality and Compliance Experience
• Corrective and Preventative Action (CAPA)
• Quality Management System Experience

Additional exposure may include the following:

• AAMI - The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485
• AATB Accreditation Experience
• Think Reliability - Cause Mapping
• Lean Sigma Trainings

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.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform 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.
A commitment to our employees' lives is 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.
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here.
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.