Our client is a Belgian company that distributes medical devices designed by reliable and internationally well-known suppliers. Over the years, this small business has become the preferred partner of hospitals and health professionals in providing bespoke solutions through its committed sales force.
The company (part of a European group) is active internationally in four main fields of activities:
- Infection Prevention: the best solution for everything related to medical hygiene
- Sterilization Equipment: supply you with solution and service for your central sterilization department
- Interventional Care: further subdivided into the Interventional Specialties, Wound care, Vital Care, Daycare and Daycare NL departments
- Surgery: further subdivided into Cardio-vascular and Spine departments, and general surgery focusing on the needs of the operating room
Each Division offers a complete package of disposables, capital equipment and services to meet its customers' changing needs.
Today the company distributes 150 reliable brands of medical devices, on the Benelux market and offers integrated solutions for different groups of customers groups in Belgium and Luxemburg. The turnover grew for the tenth consecutive year.
Responsibilities and job description
The QA-RA Specialist will provide assistance to the QA-RA Manager for the following activities:
- Administrative follow-up/supervision of customer complaints about quality issues.
- Layout and drafting of various QA-RA documents including organizational procedures, quality manual, internal audit reports
- Conducting internal and external audits: planning of audits, routine interview, reports writing
- Supervision through the commercial Divisions of the writing and inventory of ISO Work Instructions, supplier evaluation
- Supervision and verification of the environmental storage conditions of the products in the warehouse
- Insuring fulfilment of all Good Distribution Practices requirements with regard to the distribution of medicinal products
- Assistance with mandatory ISO 9001 & 13485 standards pre-audit documentary updates (quality objectives matrix and KPI’s, document management database, process sheets, annual listing of staff trainings, frequency statistics of product complaints, staff competence, list of approved suppliers
- Check through the commercial Divisions for exhaustive AFMPS-FAGG authorization/notification of current manufacturers (and getting all necessary CE certificates and declaration of conformity)
- Harmonizing the Quality within the company and providing of training to (new) staff regarding mandatory QA-RA subjects
Additional activities and beside projects
In addition to daily routine QA-RA work and of specific solving of problems:
- AFMPS-FAGG medical devices/implants inspections (3 - 4x/year)
- Raising to higher standard Hospithera QMS for recertification ISO 9001 & ISO 13485
- Setting up and implementing a QMS documentation software
- Support to INAMI-RIZIV reimbursement dossiers
- Legislation analysis and implementation of Sunshine Act / Transparency.be requirements
- Regulatory watch
- Implementing requirements for distributors regarding New European Regulation for medical devices and IVD MD
- Support to set up of UDI (Unique Device Identification) requirements within the company
- Biocides / SPF-FOD : new legislation understanding and implementation and follow-up of reporting to Authorities of the quantities of product distributed
- Maintain contacts between all support departments and commercial divisions in the company