Biocartis is an innovative biotech company that develops versatile molecular diagnostic platforms for low to highly multiplexed detection of molecular-based biomarkers.
The ease of use and operational characteristics of these diagnostic platforms will lower the entry barrier to molecular diagnostic testing.
Our company is based in Mechelen, Lausanne and Eindhoven.
We are a young organization with highly talented people who believe in doing the right thing the right way. We are driven by the challenge of working for a top entrepreneur in the biotech industry that keeps pushing its technology until it reaches a new level.
It is an exciting environment, where working hard and having fun are equally important. Respect is the keyword in our organization. We value the opinion and the input of all our employees and we believe in an open culture with lots of communication.
At Biocartis, our common goal is to be a winner in our field of expertise.
We are currently looking for a Quality Assurance Manager .
Job ID: 2011003
Job Title: Quality Assurance Manager
Job Location: Mechelen
Function Type: Full time
Preferably > 15 years of experience in healthcare industry of which min. 5 years in Quality Assurance
ISO 13485 and CFR 820 knowledge
Experience in the medical devices and/or in the IVD industry
Experience with US regulatory applications
Education Level: Academic level in engineering, chemistry, pharmacy or equivalent
Travel percentage: 5 – 10 %
Position within the organization
The Quality Assurance Manager reports to the Director Quality and Regulatory Affairs.
Purpose of the position
The Quality Assurance Manager is responsible for the operational management of all Quality Assurance activities related to the Design, Development, Manufacturing, Testing, Release and Customer related process for Biocartis Products
To ensure that QMS related procedures and work instruction are in accordance with applicable regulation.
To ensure that Biocartis products are designed, developed, manufactured, tested, released and distributed in compliance with Biocartis Quality Management System (QMS) and with regulatory requirements.
To ensure that Biocartis infrastructure (facilities, utilities, equipment, software) meets regulatory requirements and is adequately qualified.
To ensure product manufacturing and testing processes are adequately validated
To ensure timely release of components and Biocartis products to agreed specifications and in compliance with approved regulatory dossiers
To ensure inspection readiness and ensure availability of appropriate site representation during internal audits and external inspections
To ensure competence, awareness and training of assigned personnel (people management small team)
You have an Academic level in engineering, chemistry, pharmacy or equivalent.
You have preferably > 15 years of experience in healthcare industry of which min. 5 years in Quality Assurance
You have ISO 13485 and CFR 820 knowledge
You have experience in the medical devices and/or in the IVD industry
You have experience with US regulatory applications
You have an advanced knowledge, orally and in writing of Dutch and English
Customer service orientation
We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated. Of course we offer you a fitting compensation package.
CVWarehouse - 9 months ago