Soortgelijke vacatures
About Medtronic
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.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
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.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Your responsibilities
A Day in the Life
• You are in charge of the overall BRC Quality Management System’s suitability, adequacy and effectiveness;
• You take the lead in the development and maintenance of quality programs, systems, processes and procedures to ensure the QMS is compliant to ISO13485 and 21CFRPart820;
• You provide expertise and guidance to BRC process owners in interpreting corporate policies and regulatory requirements to assure compliance;
• You establish and monitor the annual BRC internal audit program and perform audits yourself;
• You coordinate and take the lead in hosting external audits from internal customers and regulatory bodies;
• You pro-actively identify, analyze and resolve (potential) quality issues within the BRC QMS by taking appropriate actions (e.g. CAPA) to ensure compliance and continuous improvement;
• You act as process owner for several supporting processes within the BRC QMS for example document control, internal audit, etc.
• You promote awareness of applicable Quality Management System requirements throughout the BRC organization;
• You provide quality metrics input for Quality Management Review.
• You are in charge of the overall BRC Quality Management System’s suitability, adequacy and effectiveness;
• You take the lead in the development and maintenance of quality programs, systems, processes and procedures to ensure the QMS is compliant to ISO13485 and 21CFRPart820;
• You provide expertise and guidance to BRC process owners in interpreting corporate policies and regulatory requirements to assure compliance;
• You establish and monitor the annual BRC internal audit program and perform audits yourself;
• You coordinate and take the lead in hosting external audits from internal customers and regulatory bodies;
• You pro-actively identify, analyze and resolve (potential) quality issues within the BRC QMS by taking appropriate actions (e.g. CAPA) to ensure compliance and continuous improvement;
• You act as process owner for several supporting processes within the BRC QMS for example document control, internal audit, etc.
• You promote awareness of applicable Quality Management System requirements throughout the BRC organization;
• You provide quality metrics input for Quality Management Review.
Your profile
Qualifications
We are looking for an experienced customer focused team player that is very pro-active and naturally taking ownership. You will be working under limited supervision.
Besides the ability to independently manage multiple tasks you dispose of good problem-solving skills with critical thinking/decision skills and a high attention to detail and accuracy.
You are a good communicator and fluent in English, both in writing and speaking, to be able to act as professional liaison for various internal and external stakeholders.
Must Haves:
• Bachelor or master’s degree;
• At least 5 years of experience in a Quality/Regulatory function with a demonstrated focus on Quality Management Systems based on the medical device industry standard ISO13485;
• Demonstrated MDSAP and in particular FDA Quality System Regulation (21CFR Part820) knowledge and experience.
Nice to haves:
• Knowledge of Medical Device Regulation (EU) 2017/745 is a strong advantage;
• Knowledge of Canadian Medical Devices Regulations (CMDR) is a strong advantage;
• Lead auditor certification is a strong advantage.
We are looking for an experienced customer focused team player that is very pro-active and naturally taking ownership. You will be working under limited supervision.
Besides the ability to independently manage multiple tasks you dispose of good problem-solving skills with critical thinking/decision skills and a high attention to detail and accuracy.
You are a good communicator and fluent in English, both in writing and speaking, to be able to act as professional liaison for various internal and external stakeholders.
Must Haves:
• Bachelor or master’s degree;
• At least 5 years of experience in a Quality/Regulatory function with a demonstrated focus on Quality Management Systems based on the medical device industry standard ISO13485;
• Demonstrated MDSAP and in particular FDA Quality System Regulation (21CFR Part820) knowledge and experience.
Nice to haves:
• Knowledge of Medical Device Regulation (EU) 2017/745 is a strong advantage;
• Knowledge of Canadian Medical Devices Regulations (CMDR) is a strong advantage;
• Lead auditor certification is a strong advantage.
We offer
Careers that Change Lives
At Medtronic Bakken Research Center (BRC) we design and manufacture a variety of commercial, clinical investigational and custom-made medical devices. In addition, we have a Translations group localizing Medtronic product documentation and software in the language of our customers. You will join the Quality department at BRC and will report into the BRC Quality Manager.
Here you can see an overview of the activities and products developed at our Medtronic BRC facility: https://www.medtronic.com/nl-nl/about/medtronic-netherlands/bakken-research-center.html
At Medtronic Bakken Research Center (BRC) we design and manufacture a variety of commercial, clinical investigational and custom-made medical devices. In addition, we have a Translations group localizing Medtronic product documentation and software in the language of our customers. You will join the Quality department at BRC and will report into the BRC Quality Manager.
Here you can see an overview of the activities and products developed at our Medtronic BRC facility: https://www.medtronic.com/nl-nl/about/medtronic-netherlands/bakken-research-center.html
