QA Manager
Location: BelgiumSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Medical Devices organization, based in Limburg Belgium.
Leading company in oral implantology
ROLE DESCRIPTION
As QA manager, you are part of the QARA team (Quality Assurance and Regulatory Affairs) and together with the team you are acting as ‘Process owner’ of the Quality Management System (QMS).
Important in this job is that you have some manufacturing background. It is not heave manufacturing, but you need to be able to communicate with operation people and tool makers.
RESPONSIBILITIES
- Local Quality Management System (e.g. CAPA, audits, calibration, complaint handling…);
- Review of process validation and design control documentation;
- Escalation of local quality topics to the global organization (monthly reporting, management review, …);
- Coordination of internal and external audits (Notified Bodies, FDA, …);
- People management of the local QA team.
REQUIREMENTS
- 10 years’ experience in medical device industry, with at least 5 years as Quality Assurance Manager;
- Fluent in Dutch and English;
- Experience in people management;
- Strong communicator, interacting with all levels of the global organization;
- Team player with good decision taking skills;
- Expert in ISO 13485, 21 cfr 820 (experience in FDA inspection is an asset);
- Experience in risk management, root cause analysis, process validation, software validation;
- Knowledge in regulation of standard and custom made devices;
- ISO 13485 lead auditor.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.