Our client is a a family business with local roots and an excellent reputation. Thanks to their combined experience, complementary businesses and skills in international development, the group can play its role as a leader in the medical industry.
The company is a partner in sterilisation services for hospitals and medical companies in the Benelux. They provide modular, tailored solutions, both onsite, offsite or through a shared services model.
Additionally, the company remains the trusted provider of nursing procedure sets with reusable instruments. Thanks to analysis and process innovation, they create quality and value for their customers.
The QA specialist will have full responsibility of the QA processes of the site and will report to the QA manager/QP of the group. He/she will work in close collaboration with the Plant manager.
What is your job?
- Daily follow up and the finetuning of the Quality Management System (QMS) of the site in Bierset.
- Management representative for the QMS of the Bierset site (EN ISO 13485:2016 Chapter 5.5.2 Management representative).
- Obtain and maintain an ISO 13485:2016 certificate for the CSSD activities for industrial partners and to obtain and maintain a preparation authorization from the Belgian Health Authorities (FAMHP) for the CSSD activities for hospitals.
- Set up a QP release and certification process for the CSSD activities for hospitals and to guarantee the GMP requirements are fulfilled.
- Host external customer audits, ISO13485:2016 audits from SGS and FAMHP inspections and to follow up the related CAPA plans.
- Organize and manage internal audits and quality tours of the site in Bierset and to follow up the related CAPA plans.
- Implement effective quality instructions, to give the required training and to assure the instructions are accurately followed at the site.
- Take ownership of the main QA processes at the site as internal auditing, complaint and deviation handling, change control and CAPA management.
- Follow up the qualification, validation, and calibration processes at the Bierset site and to assure these tasks are performed by qualified contractors and are properly documented.
- Monitor the clean room air amount of particles and surfaces microbiological activity.
- Act as main QA contact of the Bierset site for internal departments, for the whole group, for external partners and for local authorities.
- Support a culture of quality and compliance and continuous improvement.
- Provide higher management the required quality and compliance information when making business decisions for the future.
- Prepare and lead monthly Quality reviews with Customers (Industrial Partners / Hospitals).
- Collect, check for validity, and archive sterilization records.
- Coach colleagues/peers on problem solving and root cause analyses techniques.
Who is the candidate we are looking for?
Education and experience:
- Master or Bachelor in pharmacy, chemistry, engineering or equivalent;
- Minimum 3 years of experience in a Quality Assurance department of a production site of medical devices or pharmaceuticals;
- Familiar with ISO13485:2016 or GMP EudraLex guidelines;
- Familiar with lean culture;
- Fluent in French and English both spoken and written.
Skills and personality:
- Proactive personality who enjoys team work as well as being autonomous;
- Capable to work in a stimulating environment where a self-steering mentality is key;
- Growth-mentality, taking on responsibilities and working in company culture in which there is room for personal development;
- IT literate: MS Office, Excel;
- Strong communication skills;
- Problem solving capabilities;
- Data driven;
- Result oriented;
- Pragmatic approach.
Want to take this challenge?