Senior QA Leader
il y a 2 semaines
Job Requisition No
- VN7863
Work Location Name
- Liege
- Belgium
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
- Management Representative of the BVI Liege site
- Assures that all local, national and international standards and regulations are effectively implemented at the Liege Site
- Assures the effective implementation of the BVI Quality Management System including CAPA, Audits and Management Review
- Address customer quality issues and internally improve cost and competencies in process controls/validation studies, root cause analysis, failure mode and effect analysis (FMEA), and the use of process excellence tools.
- Manage training, document controls, internal audit and other required quality processes
- Promote/execute Continuous Improvement and Excellence activities for transactional Quality Processes and Manufacturing Processes. Develop and implement risk management methodologies
- Actively manage goals and objectives defined in the quality management system
- Review and approve the validation of new / changes in production processes as necessary
- Effective management of Quality KPIs to improve quality across the site
- Ensure effective implementation of the CAPA; develop and implement initiatives to improve processes proactively
- Effective handling of customer complaints
- Other duties as required
Purpose
- The Senior Quality Leader will provide leadership experience, direction and guidance to the BVI Liege facility. The position will plan, develop and control in conjunction with the Global QMS to ensure all Quality Objectives are met, as well as improvements in quality, in the operation, in the processes, the development of products, and the transfer of processes/projects are implemented in an efficient and effective manner. The position will be responsible for providing support and communication with our operations groups and clients to address design, manufacturing and other problems related to product issues.
Qualification
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
- More than 10 years of experience in MedTec or Pharma Industry. 5 years of management experience. High degree of knowledge of FDA (Class II and III) and EU medical device regulation is required.
- Excellent communication skills (oral and written) English language mandatory
- Has Ability to work collaboratively in crossfunctional teams to achieve milestones and goals
- Ability to influence and negotiate
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's / Master degree or equivalent is a computer science or Engineering discipline
- Six Sigma Black Belt desired
PHYSICAL REQUIREMENTS
- Extensive use of keyboard requiring repetitive motion of fingers.
- Extensive use of telephone and facetoface communication requiring accurate perception of speech.
- Regular sitting for extended periods of time.
- Travel expected with specific support required for inspections and site readiness activities
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