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
Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs. Our America’s Shared Services Center (SSC) is looking for an Audit Specialist (Internally and externally) based remotely in Spain.
In this exciting opportunity, you will support Compliance, Quality Management System (QMS) projects, and Change Control activities as outlined in relevant Internal Quality agreements. Additionally, you may assist in further QMS activities under the 'Put Patients First' initiative and the Global Regions Audit program, serving as an Auditor or Lead Auditor.
Responsibilities may include the following and other duties may be assigned:
- Follow up, manage, and provide guidance to audit program, audit, observations, and child Project Records (PRs) performance actions.
- Provide training to all individuals engaged in the internal and external audit processes across Global Regions, including the use of the TrackWise system
- Support and document KPIs related to the monthly audit, change control and
- Quality Management System (QMS) objectives, and provide mitigation, correction, and improvements plans in case of unaccomplished with the KPIs targets
- Collaborate closely and directly with the operating groups and the Compliant Quality System (CQS) team to provide guidance, expertise, and monitoring of all activities within the Audit, Change Control, and QMS processes. As well as analyse and work on projects in partnership with stakeholders
- Provide expertise and guidance in interpreting policies, regulations, and procedures to ensure compliance, and participate in projects within the audit, change control and QMS processes
- When acting as the owner of documents or processes, ensure that all related activities are updated and aligned with the applicable QMS requirements
- Fulfil any additional responsibilities defined in the Service agreements between the Center-Led team and other entities at the Global Regions level
Required Knowledge and Experience:
- Bachelor’s degree in Life Science, Engineering, or a related degree. (e.g. Pharmacy, Biomedical Engineering)
- At least 3 years of experience in a Quality role within the Healthcare industry, with a high focus on ISO 13485, ISO 19011, and/or GxP (Good Practice) requirements, such as Good Distribution Practice (GDP) and Good Manufacturing Practices (GMP)
- Fluent in English and Spanish (both verbal and written)
- Project management Skills
- Ability to work virtually with all parts of the region
- Capacity to serve as an independent compliance decision-maker by leveraging knowledge of regulations, available relevant information, alternatives, and associated risks
Lead or Internal Auditor certification in QMS (such as ISO 13485 or GMP) and have working knowledge of ISO 13485. Experienced in writing and reviewing technical documentation, with a solid understanding of Medical Device Regulations and the Food and Drugs Acts. Exhibit strong technical writing and documentation review skills, with keen attention to detail, and demonstrate strong critical thinking and analytical abilities.
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
