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
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We can accelerate and advance our ability to create meaningful innovations – but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
The Senior Quality Systems Specialist develops and maintains quality assurance programs to ensure that the performance and quality of Medtronic products conform to established standards and agency guidelines. Primary job responsibilities include CAPA management, audit program management and Quality Management System improvements.
Responsibilities may include the following and other duties may be assigned:
- Provides oversight for the 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 complying with policies, regulatory and/or governmental regulations, and internal regulations to assure compliance
- Product Servicing QA activities support – Technical Service Bulletins, Equipment Out of Tolerance Reports, Service procedure maintenance
- Supports audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups through all stages of the audits
- Prepares reports and/or necessary documentation (e.g., Corrective and Preventative Actions) and provides to applicable stakeholders
- Supports the quality assurance programs and policies maintenance and modification regularly
- Drive Quality Management System (QMS) & product continuous improvement through CAPA management. Elevate issues to management as appropriate
- Coach new CAPA owners through processes and best practice
- Develop and maintain Compliance policies supporting the Risk Management program
- Support process improvement projects and assessment of quality plans
- Support management during external/internal inspections and participate in the management of external/internal inspections
- Maintain working knowledge of domestic and international medical device regulations and guidance documents and their impact on Medtronic’s operations
- Leading audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits
- Co-ordinating legal requests in support of government investigations or litigations
- Ensuring the quality assurance programs and policies are maintained and modified regularly
- Facilitating uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally
Required Knowledge and Experience:
- Bachelor’s degree in engineering, Science or technical
- Fluent in English
- Five years of work experience in or Quality OR Master’s Degree Engineering, Science or technical field with three years of work experience in Quality
- Expertise in CAPA compliance & investigation techniques
- Auditing experience to ISO13485, 21 CFR Part 820 -- Quality System Regulation
- Computer literacy must include proficiency with MS Office and experience with networks and applications
Master’s degree in engineering, Program Management, or Compliance, Lead Auditor Certification to ISO 13485:2016 and strong technical experience in Service and Repair including ability to understand technical information, discuss/decide on a wide array of technical/logistical issues are advantageous.
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
