Medtronic Quality Systems Specialist in Maastricht, Netherlands
Quality Systems Specialist
Maastricht, Limburg, Netherlands
Jul 09, 2017
(Associate) Quality System Specialist
For our Bakken Research Center in Maastricht, the Netherlands.
Careers that Change Lives
At our Bakken Research Center campus in Maastricht, about 340 international talents i.a. clinical researchers, scientists, translation-, quality- and regulatory specialists and technical engineers cooperate closely with medical specialists in and outside of Europe on therapy innovation, clinical and economic evidence, regulatory approval and global translations for various Business Units within Medtronic.
A Day in the Life
We offer you the opportunity to act as (associate) Quality System Specialist in an innovative environment with a high focus on quality and compliance where you will be working closely together with other international talents in the area of Design and development, manufacturing and Translations.
The Quality System Specialist works under general supervision of the BRC QA Manager and will be part of the Quality Assurance team.
Your main duties and responsibilities will include:
In this role you are responsible for the BRC Quality Management System (QMS) and ensuring that the QMS meets the needs from the Research Technology department and the Medtronic Translations department as well as internal and external (regulatory) requirements such as Medical Device Regulation, ISO13485, ISO62304 and ISO14971.
You will be responsible as process owner for a variety of enabling processes such as Training, Document control, CAPA, Audits, Supplier management, Change control, Risk management, etc.
You will also support other process owners within the design and manufacturing of medical devices, and translations of medical device documentation and -software, as a subject matter expert on Quality Assurance and Quality Systems.
Another important aspect of the job is to drive continuous improvement activities.Furthermore you may:
Proactively analyze data and processes and identify trends for improvement opportunities
Lead or support quality improvement projects as part of a multidisciplinary team through CAPAs and/or lean sigma / A3 Problem Solving methods.
Support monitoring and management review activities
Coordinate the internal audit program and act as lead/co auditor for internal audits as well as occasional supplier audits.
Act as key auditee in case of internal audits as well as Notified Body audits.
Provide internal training on quality system requirements and procedures.
Perform periodic supplier evaluations
Master’s degree in Quality Management, (business) engineering, (health) sciences, or similar.
Min. 2 years of relevant experience within a highly regulated professional environment (preferably in the area of Medical devices or e.g. in Biotech, Pharmaceutical, Aerospace, Automotive, etc.)
Knowledge of or experience with working in a mature Quality Management System (preferably in ISO13485 or e.g. GMP or ISO9001)
Preferably experienced in Lean Sigma or Improvement methodologies
Preferably experienced in conducting (supplier) audits
Certified as an ASQ QE/SQE and/or Lean Sigma Green Belt is a plus
We are looking for a team player with a passion for quality and continuous improvement.
You dispose of critical thinking, good problem-solving skills and a high attention to detail and accuracy.
You are used to taking initiative and accountability, and you show courage.
You are eager to learn and develop and demonstrate agility.
You are a good communicator and fluent in English, both in writing and speaking.
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 www.medtronic.com/careers .
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.
Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.