celestetic.

Quality Manager — Cosmetics & Medical Devices (ISO 13485 / 22716)

Posted: 19 minutes ago

Job Description

Your missionManage the Quality Management System (QMS) to secure regulatory compliance (ISO 13485, Cosmetics GMP / ISO 22716) and operational excellence across logistics, production and suppliers.Key responsibilities·      Establish, maintain and improve the QMS: process mapping, procedures, records, document control and versioning.·      Deploy GMP best practices for cosmetics (ISO 22716) and ensure ISO 13485 compliance for medical-device activities.·      Quality Control: inspect finished products and ensure each batch meets specifications.·      Define and track Quality KPIs.·      Manage Post-Market Surveillance (PMS).·      Oversee logistics quality controls: incoming inspection, identification checks, traceability.·      Supplier quality management: assessment & qualification, SLAs, improvement plans, periodic reviews, trend/deviation follow-up.·      Plan and conduct audits: internal (process & system) and external (suppliers, logistics provider).·      Drive continuous process improvement to sustain excellence.·      Quality IT & Data: leverage Odoo ERP for traceability and build management quality dashboards.·      Sustain a quality culture: train and coach teams; promote operational excellence and compliance.Profile·      Master’s degree in Pharmacy, Bioengineering or Biomedical Sciences with a specialization in Quality.·      Proven 3–8 years’ experience in Quality within cosmetics and/or medical devices.·      Solid command of ISO 13485 and ISO 22716.·      Strong process and structuring mindset (process mapping, standardization, document control).·      Ability to implement and maintain processes and performance indicators.·      Able to multitask and manage internal and external stakeholders.·      Willing to travel occasionally for supplier management.·      Entrepreneurial mindset, able to identify improvement opportunities.Nice to have·      Knowledge of MDR 2017/745, ISO 9001, and Lean/Six Sigma.·      Experience in a multi-site environment.·      Experience with internal audits (ISO 13485/9001 internal-auditor training is a plus).·      Working knowledge of Odoo.Tools·      Office & data: Microsoft 365 (advanced Excel, PowerPoint)·      ERP: OdooLanguages·      Fluent English and French or Dutch (ideally trilingual FR-NL-EN).What we offer·      A key, visible role with cross-functional impact.·      A dynamic, fast-growing environment.·      Work within a human-sized organization.·      An attractive, evolving package with flexible hours. Location & Contract • Location: Zaventem, Belgium — on-site position based at our laboratory and logistics center. • Contract type: Permanent (full-time). • A dynamic and stimulating environment within a multidisciplinary team combining scientific precision and cosmetic innovation. • Easily accessible from Brussels and major roads, with parking available on site.

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