Our client, it is an European manufacturer of Healthcare devices, that combine the complexities of design with advanced high-precision technology. We are looking for a Quality Assurance Manager. The selected candidate?s main responsibilities will be: - To guarantee the control and follow through systems to ensure the customers are receiving product to the agreed quality standards (ISO 13485:2016, MDD 93/42 and new MDR). - To maintain the QMS active across organisation which includes risk and changes management and validations plan. - To monitor critical suppliers, quality objectives, KPIs, incoming inspections and audit process. - To promote the continuous improvement and management of nonconformances, complaints and corrective and preventative actions. - To release of product batches - To collaborate with QARA Group Director in compiling Technical Files based on Design History Files.
Minimum studies
- Degree in Sciences and/or Quality Systems.
Minimum experience
Requirements:
- Deep knowledge of ISO 13485 (2016 preferred), MDD 93/42 Medical Devices Directive and new MDR Medical Device Regulation.
- Minimum 3 years? experience working within a Quality Management System role to and applicable standard.
- Minimum 3 years? experience working in a regulated industry e.g Medical Device, Pharmaceutical or Food Industry.
Minimum languages
- English mother tongue or bilingual.
- Knowledge of Spanish.
Assessable requirements
- Attention to Detail
- Good organisation skills
- Working based on priorities
- Hard-work, persistent, methodical profile
- Resilience, autonomous and auto-motivation
- Responsible, Reliable, Trustworthy profile
- Adaptable to changing priorities
- Collaboration and teamwork: able to work as a team with colleagues, subordinates and boss.
- Ability to work under pressure
- Problem solving
- Good written
Before doing the personality test:
-The test will take about 15 minutes and will have timer. -The personality test can be done only once. -It's important to have good internet connection.
If you are ready to start the test click 'Continue', if you want to do later click 'Cancel'.
To know your level of Office automation, Internet and social networks, we need you to complete the following set of tests, which consist of 3 specific tests on Microsoft Word, Microsoft Excel and Internet and social networks.
This set of tests can be performed once. If you are ready to start, click on 'Next', otherwise if you want to leave it for later, click on 'Cancel'.
-The test will take about 15 minutes and will have timer. -The test can be done only once. -The test has multimedia content, it's important to have good internet connection . -We recommend to use Google Chrome or Mozilla Firefox.
If you are ready to start the test click 'Continue', if you want to do later click 'Cancel'.
-The test will take about 15 minutes and will have timer. -The test can be done only once. -The test has multimedia content, it's important to have good internet connection . -We recommend to use Google Chrome or Mozilla Firefox.
If you are ready to start the test click 'Continue', if you want to do later click 'Cancel'.
-The test will take about 15 minutes and will have timer. -The test can be done only once. -The test has multimedia content, it's important to have good internet connection . -We recommend to use Google Chrome or Mozilla Firefox.
If you are ready to start the test click 'Continue', if you want to do later click 'Cancel'.