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Il y a 3 mois
**Job Requisition No**
- VN8003
**Work Location Name**
- Belgium - Liege
**Worker Basis**
- Full Time
**Worker Type**
- Employee
**Applications Close Date**
- Jun 30, 2024
**Company**
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.
**Purpose**
- Execute defined quality control measures supporting the product life cycle, including testing, product release, calibration, support to investigations (complaints, technical )
- **Key Responsibilities**
- Hire personnel and manage the Quality Control (QC) team
- Develop required skills and competencies within team
- Provide technical guidance to support project quality activities
- Manages complex internal and external projects
- Manage lab infrastructure and measurement equipment, including their qualification
- Plan and coordinate QC activities
- Coordination with external laboratories
- Purchased materials and final manufactured products release
- Maintain a professional network inside and outside of the company
- Act as process owner for QC processes, including:
- Incoming Inspection
- Calibration
- Test Methods used for incoming inspection and their validation
- Final release process
- NC Management related to products incl. Complaint investigation and analysis
- Perform analysis and provide strategical recommendations to Senior Management
- Act as PRRC In accordance with Article 15(3) of EC Regulation 2017/745, in a shared responsibility ensuring that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.
**Qualification**
***: - Advanced competencies in the field of QC processes, see above.
Demonstrated knowledge of f ISO 13485, FDA cGMPs, the Medical Device (or Pharma) Regulations, and ability to interpret and apply.
- Demonstrated ability to successfully manage and complete projects in a matrix organization
- Able to manage multiple tasks simultaneously
- Strong critical and "outside the box" thinking skills
- Strong written and oral communication and negotiations skills
- Strong interpersonal skills
- Strong analytical skills
- English proficiency
- People management skills
- High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint
Education/experience:
University graduate (BSc or MSc), ideally microbiologist
- Minimally 5 yrs in QC Job family
- Experienced people manager
- Certified Quality Manager, or equivalent experience in Quality management and People management
