Quality Systems Specialist at Medtronic Singapore

Lisbon, Community of Madrid, Portugal -

Full Time

Start Date

Immediate

Expiry Date

23 Aug, 26

Salary

55440.0

Posted On

25 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Corrective and Preventive Action (CAPA), Root Cause Analysis, Project Management, Quality Assurance, Regulatory Compliance, Audit Readiness, Process Analysis, English Fluency, Objective Evidence Verification, Data Presentation

Industry

Medical Equipment Manufacturing

Description

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 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: Bachelor’s 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. Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Portugal: 27,600.00 EUR - 41,400.00 EUR | Spain: 36,960.00 EUR - 55,440.00 EUR | 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 95,000+ 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 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 95,000+ 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. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com

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Responsibilities

The specialist will partner with CAPA owners to ensure the timely and compliant execution of the CAPA process across various regions. Key duties include coordinating CAPA Board meetings, guiding root cause analysis, and maintaining quality programs to meet regulatory standards.