Our client is the global number one manufacturer of choice for our partners who are looking for the highest quality and best service in the field of Orthobiologic Ceramics. We are working with the leading companies in the medical & dental (device) industries, start-ups with compelling business ideas and engaged universities. We co-op with our customers in the United States, Europe, Asia and in Emerging Markets. We will continue to seek and deploy technological and engineering advancements. If you’re passionate about your field, we have a wide array of positions available at our HQ in Leiden. The environment is innovative, energetic and full of opportunity. Our company thrives on a diverse workforce. Due to growth in our company, we are looking for an experienced and seasoned QA/RA/QC Manager to lead, guide and to train our QA/RA/QC department. As a (Sr.) QA/RA/QC Manager within a fast-growing contract development and manufacturing organization you will be the management represented for all QA/RA/QC related matters.
What we are looking for
To ensure the consistency of our trustworthy services and the production of our clients medical Devices, they follow our processes strictly under ISO13485 Quality management system standard. We are looking for an (Sr.) QA/RA/QC Manager who can manage and maintain our ISO13485 Management system and can build a subject matter expertise on QA/RA/QC within our organization. In order to execute these tasks our new QA/RA/QC manager needs to have proven experience with EU MDR 2017/745.
What are your responsibilities?
- Overseeing and responsible for designing, maintaining, safeguarding and optimizing the quality system
- Overseeing the timely approval of QA verified documentation (Batch Records, SOP’s etc.)
- Conducting internal and external audits
- First point of contact for the Notified Body
- Overseeing and responsible for registering, investigating and reporting internal and external complaints
- Overseeing, and responsible for Corrective and preventative measures (CAPA) management
- Train, educated and manage of the complete QA/RA/QC department within our client
- Management represented for our client
Who are you?
- A minimum of bachelor’s degree in science or comparable level through experience.
- Minimum of 10 years’ experience on QA and RA within the Medical Devices industry
- Proven track record of ISO13485 Quality management system implementation and maintenance and optimalisation
- Extensive experience in quality management technical management of multidisciplinary projects supported by excellent technical practical skills, and analytical approach
- Managing and meeting all Regulatory requirements including 21 CFR 820, 510(k) technical file submission, ISO 13485
- Extensive experience with the Medical Devices Directive (MDD) and the Medical Devices Regulations (MDR)
Maybe this is the great next step in your career, or you want to know more about the opportunity? we will kindly ask you to contact ROBERT WHITE Staffing Solutions B.V. and ask for Robert de Wit via: firstname.lastname@example.org or call +31(6) 46 70 92 18