This company is one of the largest and most dynamic companies in the consumer health and personal care industry. It is active in the Pharmaceutical industry but also in the Medical Devices. They are looking now for a new QA associate for their international Medical Device team.
You will ensure compliance with ISO13485, ISO14971 and other harmonized standards and ensure compliance. lead supporting business needs in the medical device area including new product developments, roll-outs and maintenance projects.
- You will be the QA representative within certain product categories and be responsible for all QA matters
- You will agree Quality Agreements with third-parties (contract manufacturers, logistic service providers, distributors).
- Investigate quality incidents, deviations and complaints, identify and follow-up CAPA’s and supplier improvement plans
- evaluate and follow-up Change Controls together with the Regulatory Affairs team
- Supplier Qualification and Regular Supplier Auditing are part of your daily work cycle
- Support the internal QA audits
- Support technical transfers, qualification and validation work
- A Masters’ Degree in pharmaceutical or biomedical
- Knowledge of ISO13485 or ISO14971 or GMP
- At least 3 years relevant experience in Quality Assurance
- Knowledge of manufacturing processes
- You speak and write fluently English, other languages are a plus