Quality Systems Specialist

We anticipate the application window for this opening will close on - 30 Oct 2026

A Day in the Life

         

         

Bring your talents to an industry leader in medical technology and healthcare solutions – we’re a market leader and growing every day. You can be proud to part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare.

Join us for a career in IT that changes lives.

 

Careers that Change Lives

 

A Day in the Life

 

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

• Own and drive Investigations, Root Cause Analysis and resultant Corrective Actions and Preventive Actions
• Provides Quality System support and guidance to maintain compliance with all FDA and international regulatory requirements
• Provide oversight for the development and maintenance of quality systems, programs, processes, and procedures to ensure ongoing compliance with Medtronic policies and global regulatory requirements.
• Supporting the EU Surgical Operating Unit entities from a Quality Oversight perspective consisting of proactive support (example: helping, supporting entities with setting up QMS processes, audits & certifications) & reactive support related to production quality issue resolution, PHO and FCA support)
• Partnering with and influencing internal and external stakeholders to drive needed change and the execution of compliance program.
• Responsible for communicating business-related issues or opportunities to next management level
• Lead, coordination and/or preparation of internal and external audits in accordance with regulatory standards (including FDA and its equivalents outside the US as well as other government regulatory agencies / authorities) for the Operating Unit
• Perform trend analyses and report compliance observations to identify areas in need of improvement
• Investigates and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc.
• Mastering knowledge of applicable Quality, FDA (Food & Drug Administration) Medical Device Directives/ Regulation, HIPPA (Healthcare Information Patient Privacy Act) and ISO (International Organization for Standardization) requirements through the updating of policies and procedures and acting as a liaison with appropriate policy experts.                                                                      
• Excellent writing and editing skills, and computer skills.
• Travel within US and International approximately 25%.

Basic Qualitifications:

MUST HAVE:  MINIMUM REQUIREMENTS:EDUCATION REQUIRED:

• • Bachelor’s Degree
•  YEARS OF EXPERIENCE:
  • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
  • Demonstrated knowledge of all quality system elements and regulatory requirements (i.e. FDA, GMP, QSR and ISO 13485, and MDSAP) for finished medical devices with the ability to effectively implement and communicate those requirements in a government regulated healthcare industry.  Special focus on Core QMS, Design Control & Manufacturing processes/requirements.
  • Effective usage of data analysis tools, analytical and research skills, and problem-solving techniques with keen attention to detail and simultaneous understanding of the "big picture".  Desire to follow an audit trail to identify risks, non-conformances, true root cause, etc.
  • Outstanding written, oral communication, and presentation skills
  • Sound judgement, ability to make decisions, work independently, and demonstrated leadership skills
  • Ability to manage and execute on multiple critical projects simultaneously. Capable to manage multiple priorities and escalate issues.
•  NICE TO HAVE
  • 1or more years of relevant experience in a Design & Development and/or Manufacturing setting
  • Experience supporting and/or participating in regulatory inspections and audits. 

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. a7 214.2(h)(4)(iii)(A) is required.

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):$75,200.00 - $112,800.00

‌

 

This 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.