Medtronic Clinical Quality Specialist in Maastricht, Netherlands
Clinical Quality Specialist
Maastricht, Limburg, Netherlands
Jul 02, 2017
Clinical Quality Specialist
For our Bakken Research Center in Maastricht, the Netherlands.
At our Bakken Research Center in Maastricht, about 300 clinical researchers, scientists and technical engineers cooperate closely with medical specialists in and outside of Europe to develop new and improve existing therapies in Cardiac Rhythm Disease Management and Cardiovascular Surgery. Our broad range of clinical services, includes international project management, statistical advise, IT support and medical writing, which makes us Medtronic’s authority on clinical research outside of the US.
The Clinical Quality Specialist is responsible for assuring that clinical personnel across Medtronic are educated in, and operating within the international regulatory requirements and standards, Medtronic standards, and facilitating continuous improvements to processes and procedures. This will be accomplished through bringing the clinical organizations into a quality systems model of operation that will bring improved business processes and ensure that quality is built into the clinical process.
In this role you may act as an advisor on clinical quality assurance issues regarding various aspects of the clinical study phases (e.g. patient informed consent forms, investigational plans and amendments). If required you will partner with superiors to ensure escalation of compliance issues to management and/or the business unit as applicable. You may assist in planning and conducting internal audits with low to medium risk and complexity per all applicable internal audit procedures and guidance’s. This includes analyzing internal audit results and quality/compliance risks for Management Reporting as well as ensuring follow-up and providing support. You will also support external inspections at the sponsors, site, or CRO/Core Lab, and follow-up on actions.
The Clinical Quality Specialist works under general supervision, following established procedures, and provides solutions to a variety of compliance problems of moderate scope and complexity. Work is reviewed for soundness of judgment and overall adequacy.
Master’s degree in (biomedical) engineering, health sciences, (medical) biology or quality management
Min.2 years of experience in clinical research and/or quality systems
Knowledge of quality system standards
Knowledge and experience of international regulations (pharmaceutical and/or device, e.g. ISO 14155) and/or experience in Quality System regulations
We are looking for a customer focused team player with a background in clinical research and quality. Besides the ability to manage multiple tasks you dispose of good problem-solving skills and a high attention to detail and accuracy. You are used to take initiative and you demonstrate the ability to work effectively pro-active on cross-functional teams. You are a good communicator and fluent in English, both in writing and speaking. (Inter) national travel is part of the job (approx. 30%)
Medtronic offers you a professional, international, dynamical and high quality working environment, where personal development is stimulated and personal initiatives are encouraged. Your Development Plan will challenge you to further develop your personal skills and competencies, to build your career within our global organization.
Is this the position you were waiting for? Then apply directly online via jobs,medtronic.com.
As a global leader in medical technology, services and solutions, Medtronic improves the health and lives of millions of people each year.We believe our deep clinical, therapeutic and economic expertise can help address the complex challenges - such as rising costs, aging populations and the burden of chronic disease - faced by families and healthcare systems today. But no one can do it alone. That’s why we’re committed to partnering in new ways and developing powerful solutions that deliver better patient outcomes.
Founded in 1949 as a medical repair company, we're now among the world's largest medical technology, services and solutions companies, employing more than 85,000 people worldwide, serving physicians, hospitals and patients in over 155 countries. With our European Operations Center for Distribution and Shared Services in Heerlen, the Bakken Research Center in Maastricht, our manufacturing facility in Kerkrade, and the Medtronic Eindhoven Design Center and Dutch sales office in Eindhoven, Medtronic Netherlands has more than 1,500 employees.
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