Medtronic Quality Systems Specialist EMEA in Madrid, Spain
Quality Systems Specialist EMEA
Sep 16, 2021
Quality Regulatory Systems Specialist EMEA
Careers that Change Lives
Our Integrated Health Solutions (IHS) team members are seasoned professionals with in-depth knowledge of the healthcare value chain, as well as breadth of experience across multiple disciplines. When you are working in this team, you will be a partner towards hospital management teams to drive complex transformational change, implement innovative growth strategies, streamline patient-focused care pathways and run and optimize operations.
A Day in the Life
In your role as Quality Regulatory Systems Specialist, you are responsible for maintenance and improvement activities concerning the IHS Quality Management System (QMS). Youll ensure that performance and quality of services provided to customers conform to established quality standards and regulatory guidelines to ensure customer satisfaction.
Maintain and improve the IHS Quality Management System, including:
Completion of quality and regulatory implementation activities during service activation;
Provide quality and regulatory support to designated IHS accounts (hospitals) during service delivery;
Prepare and/or support internal functions and IHS QA RA management with the delivery of quality reports (eg.; KPIs, quality performance reports);
Perform supplier quality related activities (eg.; supplier qualification and approval activities);
Preparation activities concerning external (e.g., Certification Body) and corporate audits at IHS premises;
Be part of the IHS Auditors pool and execute internal audits applicable to internal processes and customer account activities;
Support Process Owners/delegates with maintenance / update of QMS documentation;
Monitor Complaint Handling and Corrective Action (CAPA) systems, perform root cause analysis and propose improvements;
Support Process Owners with analysis and monitoring of customer feedback;
Manage Field Safety Corrective Actions;
Perform quality awareness trainings and communication activities;
Research and report on any Quality System topics and/or Regulatory topics as requested by QA management.
Participate in designated projects concerning service, healthcare quality or regulatory related activities;
Maintenance and improvement activities concerning the IHS Quality Management System.
A minimum of 3 years of relevant quality working experience in medical technology, logistical and operational environment, or healthcare service environment;
Experience in international business environment;
Experience in the medical devices industry, distribution/logistics/operations and/or service/solution-oriented environments;
Supplier management quality experience including supplier selection, supplier auditing, supplier monitoring and issue resolution;
Knowledge of international quality standards and regulations (e.g., FDA 21 CFR 820, ISO 9001, ISO 13485, MDR);
Knowledge of risk management/assessment techniques (e.g.; FMEA);
Quality Auditor experience.
Ability to read, express and report in fluent English. Additional language skills are a plus;
Analytical ability practical approach; problem-solving;
Good communication/presentation skills;
In our 5th Tenet of our Mission we recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the companys success.
Also a competitive package is of course part of that. We offer a competitive salary and benefits package to all our employees:
Flexible working environment;
Annual Incentive Plan % depending on company results;
Pension scheme and group discount on healthcare insurances;
Training possibilities via Cornerstone/Harvard Manage Monitor/GetAbstract;
Employee Assistance Program and Recognize! (our global recognition program).
Is this the position you were waiting for? Then please apply directly via the apply button!
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.
Lets work together to address universal healthcare needs and improve patients lives.Help us shape the
Founded in 1949 as a medical repair company, were now among the worlds largest medical technology, services and solutions companies, employing more than 86,000 people worldwide, serving physicians, hospitals and patients in over 155 countries.
Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your own career. Join us in our commitment to take healthcare Further, Together.
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.
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