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Quality Systems Specialist

0-2 years
$71,200.00 - $106,800.00
10 April 29, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Quality Systems Specialist
Location: Memphis, Tennessee, United States of America
Time Type: Full time
Posted On: Posted 5 Days Ago
Time Left to Apply: End Date: May 1, 2025 (1 day left to apply)
Job Requisition ID: R22662

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

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

  • Provide oversight for the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.

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

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

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

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

  • Coordinate legal requests in support of government investigations or litigations.

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

  • Facilitate uniform standards worldwide and enable best practice sharing, fostering the achievement of the company's mission globally.

Must Have: Minimum Requirements

  • A Baccalaureate degree and a minimum of 2 years of work experience in Quality or regulated industry or advanced degree with 0 years of work experience in Quality or regulated industry.

Nice to Have

  • Quality Management or Document Control experience.

  • Working knowledge of Microsoft Office tools, desktop publishing software experience (Microsoft Office Suite, Adobe Acrobat).

  • Familiarity with modern ERP (Enterprise Resource Planning) systems, PLM (Product Lifecycle Management) systems, and manufacturing documentation (i.e. BOMs, item masters, DHF, DMR, etc.).

  • Excellent communication skills (oral and written).

  • Able to work independently and within a team.

Physical Job Requirements

The above statements describe the general nature and level of work being performed by employees in this position, but they are not an exhaustive list of all the required responsibilities and skills. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Benefits & Compensation

Medtronic offers a competitive salary and flexible benefits package. A commitment to our employees' lives is at the core of our values. We recognize their contributions, and they share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

  • Salary Range (U.S. locations, excluding Puerto Rico): $71,200.00 - $106,800.00

  • This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

Additional Benefits

  • Health, Dental, and Vision insurance

  • Health Savings Account, Healthcare Flexible Spending Account

  • Life insurance, Long-term disability leave

  • Tuition assistance/reimbursement, Simple Steps (global well-being program)

  • 401(k) plan plus employer contribution and match

  • Short-term disability, Paid time off, Paid holidays

  • Employee Stock Purchase Plan, Employee Assistance Program

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required by applicable state law, and the Employee Stock Purchase Plan.

Further details are available at the link below:

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly tackle 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 95,000+ passionate people. We are engineers at heart, putting ambitious ideas to work to generate real solutions for real people.

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.