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Engineer Quality Assurance
J&J Surgical Vision in Groningen is the Center of Excellence for the development of innovative solutions for the surgical ophthalmic market, mainly intraocular lenses (IOLs). The site is responsible for the design and manufacturing of these products.
The organization is divided into 5 core teams which generally work on a project basis and according to strong quality guidelines, in an international environment.
De functie / The role
Responsible for Quality Assurance support to Quality Control Laboratory, Mechanical- Optical Laboratory and product release process. Supports improvement of Quality Control and Mechanical-Optical laboratory related test methods and equipment related to product development and product release testing.
GMP/CORE JOB RESPONSIBILTIES
o Initiates, validates and implements improvements in laboratory related matter, such as cleaning validation and test methods when necessary
o Investigates and resolves lab related Corrective and Preventive actions (CAPAs)
o Supports activities for the test labs related to process engineering, such as implementation of new measurement devices including performance of Installation Qualification / Operation Qualification (IQ/OQ) and test method validation
o Maintains and generates as necessary lab work instructions and forms to assure continued compliance to applicable external requirements
Het profiel / Your profile
Educated to a senior vocational education level in Biology, Chemistry or a Life Sciences/Biomedical Engineering related discipline; BSc or equivalent qualification
A minimum of 3 years" experience in a laboratory environment, preferably in the execution of environmental monitoring, testing and validation of test methods and critical utilities
experience/knowledge with sterilization
Knowledge of GMP and ISO 13485
Knowledge of USP 1072
Knowledge of sterilization (Ethylene Oxide and Gamma)
Knowledge of relevant work instructions and procedures
Ability to manage a number of competing priorities
Ability to achieve quality improvements in a flexible manner and with changing priorities
Good analytical ability
Excellent oral and written communication skills in the English language