Associate Quality Systems Specialist (1-year contract)
Associate Quality Systems Specialist (1-year contract)
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1 Vacancy
Job Description
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
The Associate Quality Systems Specialist leads and manages Post Market Surveillance (PMS) activities related to Field Safety Corrective Actions (e.g. recalls corrections removals). You will collaborate with cross-functional teams and regulatory authorities to manage field actions effectively and ensure patient safety in EMEA and Canada.To be successful in this role you are a pro-active quality focused team player who is not afraid to speak up ask critical questions and take the lead in discussions when needed. You have a strong focus on regulatory compliance process management and are able to build lasting relationships with colleagues in other departments and disciplines. Managing several operational tasks and projects at once poses no problem for you. You have strong presentation skills and can communicate confidently and clearly across all levels of the organization. You bring a first time right mindset consistently aiming for accuracy and quality in every task. This role is based in the Netherlands Heerlen. This position would be an initial 1-year contract.
Responsibilities may include the following and other duties may be assigned:
- Review and assess Global field action plans to ensure alignment with regulatory expectations in EMEA and Canada. Provide regulatory guidance during field action planning meetings
- Collaborate with Quality Marketing Legal Supply Chain Country Regulatory and other teams to implement effective field action strategies
- Prepare regional documents to support the Field Safety Corrective Actions within EMEA and Canada
- Prepare and submit Field Safety Corrective Action notifications to regulatory authorities (e.g. EU Competent Authorities EU Notified Bodies Health Canada)
- Ensure timely and accurate communication of field actions to stakeholders including internal teams customers and regulatory bodies
- Initiate and implement process improvements
- Design maintenance and implementation of departmental systems and procedures.
Required Knowledge and Experience:
- Bachelors degree in a related field (e.g. Industrial Engineering Regulatory Affairs Biomedical Engineering Life Sciences)
- 02 years of experience in regulatory affairs quality process management or a related area (internships or experience in the medical device industry is an advantage)
- Basic understanding of global regulatory requirements for medical devices (e.g. FDA EU MDR ISO 13485 Health Canada SOR/98-282)
- Strong problem-solving skills attention for detail and ability to manage complex situations
- Think critically challenge assumptions and have the confidence to speak up and engage constructively in meetings
- Strong presentation and Excellent Microsoft Office skills (advanced Excel experience and SAP knowledge are considered an advantage).
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.
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 95000 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
Required Experience:
IC
Employment Type
Full-Time
