QA Qms Specialist
il y a 1 semaine
**Job Requisition No**
- VN7913
**Work Location Name**
- Belgium - Liege
**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.
**Key Responsibilities**
**Improvement**
a) Supports and performs Quality Management System process improvements
- b) Identifies improvements & inputs into the quality planning process
- c) Collects, analyses and communicates QMS performance data (KPI's)
- d) Identifies and implements improvement opportunities to increase the efficiency and effectiveness of the Quality Management Systems.
- e) Contributes to the development, maintenance and improvements of procedures, work instructions and forms.
- **Support**
f) Contributes to the Management Review Process and Quality Planning, including the collection and analysis of related KPI's
- g) Supports business during external audit
- h) Supports internal audit program
- i) Supports Deviations and CAPAs processes linked to QMS
- j) Supports Change Control process
- **QMS processes**
k) Ensures QMS reflects actual activities and business needs, and supports NPD requirements
- l) Performs QMS activities to ensure project milestones of assigned projects are met.
- m) Maintains QMS Training program and monitor execution thereof
- n) Performs document control activities
- o) Organizes archiving process
- **Purpose**
- Actively participate in the management of the Liège site Quality System for compliance and effectiveness.
- **Qualification**
**REQUIRED KNOWLEDGE, SKILLS AND ABILITIES**
Knowledge
- Competencies in the field of Quality Management Systems, incl.:
- a) Quality management system, structure and compliance
- b) Management review
- c) QMS Training
- d) Management of external audits
- e) Internal audits
- f) Deviation & CAPA
- g) Document and data control
- h) Change Control
- i) Archiving
- **Skills**:
- Strong interpersonal skills
- Strong Analytical skills
- English proficiency
- High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages
- Basic knowledge of our internal processes and activities, other than QMS related
- Abilities
- Ability to establish and maintain effective working relationships with co-worker’s, managers and clients
- Ability to communicate to managers and co-worker’s
- **MINIMUM REQUIRED EDUCATION AND EXPERIENCE**
University or high school graduate in life sciences (Bachelor or Master)
- Minimum 2-3 years experience as QA/QMS officer in the field of a medical devices or pharmaceutical manufacturing site
- **PHYSICAL REQUIREMENTS**
Use of keyboard requiring repetitive motion of fingers
- Use of telephone and face-to-face communication requiring accurate perception of speech
- regular sitting or standing for extended periods of time.
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