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
Career growth and development is about learning and stretching yourself to grow your expertise and navigate your career. Medtronic offers award-winning programs to accelerate your development and growth. Our size, scope and market leadership give you the chance to explore career opportunities and grow as we grow.
As a Quality Systems Specialist, you will support Internal and External Audit activities across Compliance, Quality Management Systems (QMS) projects, and Change Control projects. You will also extend support for additional Quality Management Systems activities under our Put Patients First initiative and Global Regions Audit program as Auditor or Lead Auditor.
Responsibilities may include the following and other duties may be assigned:
Work closely with Medtronic operating groups and the Configuration Quality Systems teams to provide guidance, knowledge, and monitoring of all activities within the Audit/Change Control/Quality Management Systems processes.
Document KPIs related to the monthly Audit/Change Control/Quality Management System objectives. Provide mitigation, correction, and improvements plans, in case of unaccomplished KPI targets.
Provide training to all the people involved in the Internal and External Audit process, across Global Regions, and across the TrackWise system.
Ensure compliance to policies, regulations and procedures by providing guidance
Participate in Global Regions Audit programs as an Auditor or Lead Auditor, and participate in projects for Internal and External Audit/Change Control/Quality Management Systems
If needed, act as the Document Owner, and ensure all activities and processes are updated and aligned with the Quality Management Systems guideline
Identify and develop opportunities for process improvements within the quality management system. Develop project plans, timelines, and budgets, and monitor project progress against these plans.
Must Have:
Bachelor's Degree is required
Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience
Your Profile
Bachelor's Degree in Life Science, Biomedical Engineering, or Pharmacy
Previous experience in a Quality Management Systems role within the pharmaceutical or medical devices industry
Knowledge on ISO 13485 and/or GxP requirements. (eg Good Distribution Practice (GDP), Good Manufacturing Practices (GMP).
Good understanding of Medical Device Regulations and the Food and Drugs Acts.
Able to work closely with stakeholders across all functions and regions of the organization
Experience with technical writing and documentation
What We Offer
We recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company's success. We believe in rewarding our staff with a complete package of benefits designed to support them at every career and life stage. As a result, our employees have access to the following benefits, to name a few:
Our global well-being program supports your physical, emotional, social and financial well-being.
Medtronic Employee Assistance Program offers confidential support and resources to build and enhance employee and organizational resilience, productivity, teamwork and psychologically healthy workplaces.
Various insurance benefits include Inpatient and Outpatient Medical Insurance, Life, Disability and Accident Insurance.
We have generous employee referral programs, employees stock purchase plan, leave benefits, and more
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 90,000+ 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
