Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Work with us to incentivize better patient care and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.

We are seeking a driven and talented individual to join our IT Quality, Compliance and Risk organization. This individual will bring a passion for continuous improvement, a strong communication skill set, and an ability to have an attention to detail as they relate to the QMS processes we support.

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

• Provides oversight for the development and maintenance of 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 analyses oversight on a continuing basis 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 (Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external
• Co-ordinates 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

Required Knowledge and Experience:

• Bachelor’s degree
• 2+ years of experience supporting IT quality, compliance, or validation activities in regulated industries
• Experience in CAPA including facilitating root cause analysis
• Project Management skills
• Life Science experience
• Familiarity with regulations and standards such as ISO13485, FDA 21 CFR Part 11 and EU Annex 11.

Nice to have:

• Previous Medtronic experience
• Product, non-product or healthcare software validation delivery experience
• Lean six sigma green / blackbelt or DMAIC skills
• MA&D IT experience or similar audit experience

 

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. 

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Recruitment Fraud Alert 

We are aware of phishing scams targeting job seekers. Please keep the following in mind: 

Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. 

Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. 

If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. 

If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com. 

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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.
 

 

 

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