Quality Systems Specialist
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Job Summary
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
Working in the Center-Led CAPA team offers the opportunity to support a broad portfolio of products and contribute to outcomes that impact both current and future patients. The team works closely with CAPA Boards across the Americas EurAsia and Operations providing visibility and collaboration across multiple operating units platforms and enterprise functions. As part of the Quality organization the team is committed to driving operational excellence while keeping patients at the center of every decision recognizing the real human impact behind the work we do. For this remote role you will be expected to be based in Spain or Portugal.In this role exiting role as a Quality systems Specialist you will partner with Corrective and Preventive Action (CAPA) owners across regions to support the timely and compliant execution of the CAPA process. You will coordinate and document CAPA Board meetings guide CAPA owners through key phases such as root cause analysis action planning execution and effectiveness checks and verify that each step of the process is completed with clear and robust objective evidence. You will also prepare and present data on CAPA process performance and compliance for the relevant CAPA Boards while supporting internal and external audits and managing business-related activities in English.
Responsibilities may include the following and other duties may be assigned:
- Provide oversight for the development implementation and maintenance of quality programs systems processes and procedures to ensure compliance with internal policies and external regulatory standards
- Provide expertise and guidance in interpreting internal policies regulatory requirements and governmental regulations to ensure consistent compliance
- Partner with operating entities to perform ongoing process analysis and oversight ensuring adherence to requirements and regulatory expectations
- Lead audit and inspection readiness activities manage the resolution of findings and liaise with auditors and inspectors throughout all stages of the audit process
- Prepare and maintain reports and required documentation including Corrective and Preventive Actions (CAPAs) for relevant internal and external stakeholders
- Coordinate legal and compliance-related requests in support of government investigations or litigation matters
- Promote consistent quality standards globally by supporting the maintenance and continuous improvement of quality assurance programs and enabling best practice sharing across the organization
Required Knowledge and Experience:
- Bachelors degree in Life Science Engineering or a related degree. (e.g. Pharmacy Biomedical Engineering)
- At least 2 years of experience in a Quality role within the Healthcare industry
- Fluent in English (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
Medtronic is committed to safeguarding the principle of non-discrimination in employment on the basis of sex sexual orientation or gender identity as set out in Article 14 of the Constitution and Articles 17 and 18 of the Workers Statute as well as Organic Law 3/2007 of 22 March on effective equality between women and men and Law 4/2023 for the real and effective equality of transgender people and the protection of LGTBI rights. This commitment applies to all company personnel without exception. This is done with the understanding and conviction that equal treatment and opportunities in the workplace must be guaranteed ultimately ensuring an inclusive working environment that advances the eradication of discrimination against LGTBI people and the absence of any direct or indirect discrimination on the grounds of sex sexual orientation gender identity and expression and those derived from maternity family obligations and marital status.
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
About Company
About Medtronic 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 excit ... View more
