QA Project Leader

**Job Requisition No**
- VN7881

**Work Location Name**
- Liege - Belgium

**Company**

**COMPANY OVERVIEW**

BVI® is refocusing the future of vision.

As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries.

We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept - taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.

**Key Responsibilities**

**KEY RESPONSIBILITIES**
- Participation in the realization of regulatory files related to new products (PMA, CE file, registration, etc.) and incremental improvement of products
- Project management related to quality assurance processes. Support for various follow-ups with internal and external stakeholders
- Support for regulatory monitoring and the implementation of changes related to the evolution of international and national standards (MDSAP, ISO 9001, ISO 13485, MDR, etc.)
- Control of process compliance after implementation of project improvement actions.
- Evaluation & monitoring of changes in terms of quality (organization, documentation, validation, training, premises, investments, suppliers, products...)
- Proposal of improvements and/or evolutions in the field of quality according to the actions resulting from the projects
- Raising awareness and informing the departments concerned about the quality approach and the improvements made by the projects
- Analysis of the evolution of quality systems and tools and definition of their implementation
- Prepare and participate in Management Reviews and other leadership meetings as required
- Active participation in internal and external assurance audits
- Internal Auditor
- Plan and perform initial and ongoing training on QMS (non-product related) processes

**Communication on the Quality System**
- Communicate any customer complaint, non-compliance to the manager(s) and the QA Director, forward the completed non-compliance form if required.
- Communicate to the manager(s) and the QA Director any unusual facts or problems that could affect the smooth running of the tasks to be performed.

**Purpose**

**PURPOSE**

Support in the definition and coordination of the implementation of quality assurance processes (organisational methods/manufacturing processes/products/audit)
- **Qualification**

**QUALIFICATION**

**Education & diploma (minimum) required**: Univ-Master Science level or equivalent
- (CESS: Certif. Ens. Sec. Sup - ESTC: Ens.Sup.Type Court (3 years) - ESTL: Ens.Sup.Type Long (4 years) - Univ-Master (ex-license) - Univ-Doc: doctorate)_

**Experience**: 3 to 5 years in similar function (if possible project management)
- **Technical knowledge and skills**: AN TECH L-E-P
- AN: English - NLS: Dutch - Other: other language_
- TECH: technical - COMM: commercial - SCI: scientific - TERR: language commercial territory_
- L: read - E: written - P: spoken_