PROJECT MANAGER QA/RA
We are looking for an experienced Quality Assurance and Regulatory Affairs Manager for a revolutionary medical testing device.
We kijken ernaar uit van je te horen.Solliciteer nu
| JOB DESCRIPTION:
You will take ownership of all quality and regulatory responsibilities involved in the development of a novel IVD solution. This includes setting up a lean quality management system on a project level, to ensure correct design control documentation; helping define the correct product definition and clinical claims and lead the interaction with the regulatory bodies and experts. You will interact with the technical leads to write product development processes and plans in accordance with the ISO13485 standards and guide them in the execution of these plans. You will audit suppliers and manage the relation with them on a quality level. Your responsibilities:
- Lead the introduction of a quality management system following ISO13485, on a project level
- Lead the introduction of design control thinking into the product development
- Define the product definition and clinical claims together with the stakeholders
- Interact with technical teams to write the product development processes and plans
- Interact with suppliers and sub-contractors to assure compliance with the regulations
| WE ARE LOOKING FOR:
- Extensive experience in setting op QMS and design controls for complex medical products
- Experience in IVD development is a strong plus
- Experience with supplier audits / management is a plus
- Experience with the technical aspects of assay and product development is a plus
- You are comfortable with both hands-on work and high level regulatory discussions and have a practical mindset
- A team player with excellent communication skills and fluent in English
| WHAT YOU CAN EXPECT OF TMC:
TMC is a technology and science consultancy company that brings expertise to their clients in order to support them with the realization of their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients in order to help them to be more competitive in an ever more global and faster changing technological world.
TMC is truly unique thanks to our business model called the Employeneurship model which comes as a true innovation for the High Technology consulting business. It's the business relationship of the 21th century for high skilled Engineers & Scientists, and our model is built around 5 main pillars:
- Permanent employment contract, offering you stability and security
- Individual profit sharing: know your market value and share in the profit your work generates
- One-on-one coaching and trainings designed to help you develop your entrepreneurial skills
- The competence cells structure, providing a strong relevant network
- The entrepreneurial lab: a playground for new ideas and a launching for start-ups
TMC is an equal opportunity employer and values diversity. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Past TMC perfect bij jou? We kijken ernaar uit van je te horen.
Feel Free to Contact