Our client is a reputable company developing a unique medical device for the non-invasive diagnosis and treatment of atrial fibrillation with massive global importance.
As a result of the successful growth, they are looking for a Quality Assurance Specialist to join their team. The successful candidate will support the engineering and manufacturing teams and contribute to the effective operations of the company. Your responsibility will be also conducting the QA review of equipment documentation.
The successful candidate has experience with quality assurance in a manufacturing environment, ideally in the biotech industry where he/she has gained experience in QMS planning and implementation.
If you are an ambitious and knowledgeable professional, this is a great working environment with opportunities to develop your skills and knowledge while working with cutting-edge technology. By working for our client, you can help make a difference in the lives of millions around the world.
Relocation support provided for the right candidate.
- Work closely with the manufacturing team to conduct the QA review of production Device Master Record documentation
- Cooperate with the engineering team to conduct the QA review of the verification and validation documentation, such as test protocols, test reports, investigation reports, and engineering change requests
- Managing the QA review of process validation and software tool documentation, such as test protocols and test reports
- Research and answer questions of a technical nature in the interpretation of construction codes and standards
- Conduct the QA review of Device History Records
- Delegate the QA review of Device History Records (DHRs) to support finished goods release
- Lead root cause investigations (targeted DHR review)
- Guide the QA review of equipment documentation
- Minimum 3 years of QA experience in a manufacturing environment/ biotech industry preferred
- Proven knowledge in QMS planning and implementation, including the documentation required for a product release such as Certificates of Conformances and Device History Records
- Knowledge of ISO 13485, FDA QSR plus QMS requirements of the European MDD
- Bachelor of Science degree in a technical discipline
- Hands-on experience with QA review and approval of the following: (facility and equipment qualification protocols and final reports, design verification and validation protocols and final reports, cleaning validation protocols and final reports and analytical test method validation)
- Dynamic, self- motivated professional with a great team spirit
- A detail- oriented person with great analytical skills