We are a medical device company in the field of contact lenses, and we are looking for
Quality Engineer to join our team. youll be part of a growing global business with a presence
in over 40 countries.
What will you be doing:
As our Quality Engineer you will report directly to the Quality and Regulatory Manager.
As part of your responsibilities cross-functional interaction throughout the organization will be
required to support all current and new products.
Collaborative teamwork is a must, to support multiple priorities and education to other departments. Achieves operational
objectives. Analyzes and resolves problems. Performs quality assurance activities.
Part of your responsibilities will be:
- Maintain and develop the existing Quality Management System procedures and
processes through Continuous Improvement projects.
- Act as the key contact for Quality and compliance activities assisting in all quality
related aspects of manufacturing to ensure best practice is adopted.
- Carry out risk management activities.
- Write, review and approve as needed validation protocols (e.g. IQ, OQ PQ) for
manufacturing equipment and processes.
- Lead statistical analysis for sampling plan rationale and analysis.
- Perform internal and external Audits to maintain Quality System Regulation
requirements.
- Support company goals and objectives, policies, and procedures in compliance with
quality manual and quality system processes such as CAPA system, change control, etc.
- Investigates instances of nonconforming material and facilitates the determination
of root cause and corrective action/preventive action.
-Leads teams responsible for the improvement activities.
Requirements: - A good working knowledge of medical device manufacturing processes MANDATORY
- Working experience in medical device companies - MANDATORY
- A good working knowledge of medical device manufacturing processes
- Knowledge of Quality systems and ISO 13485 requirements.
- Self-starter and able to work both independently and as a leader of an integrated, interdisciplinary team in carrying out assigned responsibilities.
- Fluent command of spoken and written English.
- Ability to communicate and influence effectively with other departments to achieve objectives.
- B.Sc. in Engineering
- 8 years of experience as a Quality Engineer, or similar role in the medical device field.
- 8 years of experience as a Quality Engineer, or similar role in the medical device
המשרה מיועדת לנשים ולגברים כאחד.