Our client is looking for a QA engineer to join their Quality Assurance team, located in Groningen.
In this role, you will be expected to perform the following tasks:
- Ensure quality assurance within product and process development projects
- Perform and assess statistical analyses and support the implementation of statistical process control techniques, sampling schemes and other quality techniques
- Assess and partly determine specifications for raw materials and consumables, processes, semi-finished products and end products in relation to internal and external quality standards
- Drafting and reviewing protocols and reports
- Review all changes to product specifications
- Advising, reviewing and approving changes in products/processes or systems, in line with the applicable procedures. Approving all QMS related procedures and work instructions
- Continuous improvement of the focus area in response to regulatory developments, trends, deviations or other data-driven input
- Addressing non-conformities within production and taking care of internal escalations
- Guiding planned deviations from the production process
- Advising, reviewing and (approving) changes in production processes, in line with the applicable procedures
- Analysing data on rejects within the production process for continuous improvement and reducing or eliminating sources of variation within the production process
- Provide support regarding the qualification of equipment/process/computerized systems ensuring that the validation approach, output and documentation comply with applicable procedures.
To qualify this role, a potential candidate should meet the following requirments:
- HBO education (preferably in the direction of Technology)
- 2-4 years of relevant work experience, preferably in the pharmaceutical or medical-device industry
- Knowledge in GMP, MDD/MDR, QSR CFR 820, ISO 13485, ISO 14971
- Quality Assurance Systems (QMS) and relevant work rules and procedures
- MS Office
- Validation of technical systems and processes, and statistics and quality improvement techniques
- Excellent command of Dutch and English language
If you are interested in this role, please get in touch with me by sending me your CV at anthony.o’ or contact me at +31 20 888 8411.
Vivid Resourcing are committed to equality of opportunity for all applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships or any other characteristic protected by law.
