PlusOne

QA Manager - Medical Devices - Freelance

Company

For our client, 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.

To reinforce their team, they are currently looking for an experimented QA Manager for a Freelance contract (3 Months).

Role & Responsibilities

The QA Manager Freelance will provide assistance to the QA-RA Manager for the following activities:

  • Conducting internal and external audits: planning of audits, routine interview, reports writing
  • AFMPS-FAGG medical devices/implants inspections (3 - 4x/year)
  • Raising to higher standard company QMS for recertification ISO 9001 & ISO 13485
  • Supervision through the commercial Divisions of the writing and inventory of ISO Work Instructions, supplier evaluation
  • Insuring fulfilment of all Good Distribution Practices requirements with regard to the distribution of medicinal products
  • Expertise 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

Profile

  • (Industrial) Pharmacist (Master, PhD) or equivalent by experience
  • English: Fluent spoken and written
  • Dutch and French: working proficiency
  • Active knowledge of GDP (Good Distribution Practices), ISO 9001 and mainly ISO 13485 standards and qualified for conducting internal audits
  • 3 to 15 years of experience in Quality Assurance Management in the medical device sector
  • High organizational skills, good interpersonal skills, flexibility in tasks and schedules
  • Sense of responsibility, enthusiasm and leadership

Offer & Contact

Our offer

  • Freelance contract
  • 3 months mission part-time
  • Very flexible scheduling
  • Location: Brussels Center (very close to the Brussels South Train station)
  • Start date: March 2019

How to apply

If you are interested in this challenging opportunity, please address your application (CV and short motivation text, both in English) to our recruitment partner, Plus One:

Publication date

31.01.2019

Contact person

Minet

All vacancies
Plus One uses cookies to remember certain preferences and align jobs interests.