Senior Quality Systems Specialist
Listed on 2025-12-31
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Quality Assurance - QA/QC
Quality Engineering
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Application window closes on 2 Jan 2026.
A Day in the LifeAt Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. You’ll work a minimum of 4 days a week onsite and collaborate cross‑functionally to engineer the extraordinary.
Responsibilities- Contributes to the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with global policies, local regulations and practices.
- Supports monitoring and evaluation of process performance and quality to ensure conformance with internal and external standards.
- Provides guidance in interpreting policies, procedures, and external regulations to ensure compliance.
- Partners with cross‑functional teams to identify and resolve compliance gaps and quality issues.
- Supports audit and inspection preparation, execution, and resolution of findings.
- Supports operating‑unit and enterprise change control processes.
- Supports the field corrective action and product hold programs.
- Supports monitoring of key performance indicators and contributes to identifying improvement opportunities.
- Prepares QMS reports and provides necessary information to applicable internal and external stakeholders.
- Contributes to training and awareness initiatives that foster quality culture and compliance.
- Baccalaureate degree.
- Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
- Strong understanding of quality and regulatory system standards such as ISO 13485 and ISO 14971.
- Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or similar certification.
- Creative thinking, embraces new approaches, and maintains strong attention to detail.
- Demonstrates curiosity and a drive for continuous improvement.
- Proficiency with data analysis and visualization tools (MS Excel, Power BI, etc.).
- Strong analytical and problem‑solving skills.
- Effective verbal and written communication skills.
- Experience with ERP systems (e.g., SAP).
Job Requirements
The above statements describe the general nature and level of work performed by employees in 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 and 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.
Medtronic offers a competitive salary and flexible benefits package. Salary ranges for U.S. (excl. PR) locations (USD): $89,600.00 – $. This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP).
Benefits for employees who work 20+ hours per week include:
- 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
- Simple Steps (global well‑being program)
Benefits for all regular employees include:
- 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)
- Capital 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. Some benefits may not apply to workers in Puerto Rico.
Equal Employment Opportunity (EEO) StatementIt 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.
Mid‑Senior level
Employment typeFull‑time
Job functionQuality Assurance
IndustriesMedical Equipment Manufacturing, Hospitals and Health Care, and Pharmaceutical Manufacturing
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