Quality Systems Spec

Job Description:

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
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. 

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).

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 95,000+ 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