We anticipate the application window for this opening will close on - 3 Jan 2025

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

A career at Medtronic is like no other. We’re purposeful. We’re committed. 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 & 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, as well as other duties that 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 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, resolves audit and inspection findings, and liaises with auditing groups and inspectors through all stages of the audits.
• Prepares reports and necessary documentation (e.g., corrective and preventative actions) and provides them 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 the 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  

To be considered for this role, please ensure the minimum requirements are evident on your resume.

- Bachelor’s degree required

- Minimum of 7 years of quality systems experience or advanced degree with a minimum of 5 years experience

Nice to Have (Preferred Qualifications)

• HCT/Ps are subject to the regulations in 21 CFR 1271, including establishment registration, donor eligibility (donor screening and testing), Current Good Tissue Practice (CGTP), additional regulatory requirements
• 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

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. 

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.

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.
 

Salary ranges for U.S (excl. PR) locations (USD):$110,400.00 - $165,600.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance,Health Savings Account,Healthcare Flexible Spending Account,Life insurance, Long-term disability leave,Dependent daycare spending account,Tuition assistance/reimbursement, andSimple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees:Incentive plans, 401(k) plan plus employer contribution and match,Short-term disability,Paid time off,Paid holidays,Employee Stock Purchase Plan,Employee Assistance Program,Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), andCapital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns.  Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

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 90,000+ 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.

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.