Assure that products are developed according the defined Research and development process as a contribution to overall product quality in a pro-active way.
The Quality Assurance (QA) officer plans and implements the project, product and organizational quality assurance activities to ensure that the defined development processes and standards are deployed, followed and improved. The QA officer is the Project Manager's partner concerning the quality of the development processes, which means signaling, advice, support, escalating and reporting to the organization ( until Quality Manager).
Furthermore the QA is responsible for the pro-active adaptations of the procedures towards the way of working within Research and in line with the external regulations.
Key areas of responsibility
Monitoring: This means evaluating activities (completeness and quality level) in the project and monitor compliance with the projects' plans and the projects' Q-system requirements.
To verify project plan (incl. CM-plan, V&V-plan, RM-plan) against applicable standards
To monitor the completeness of the Design Input requirements
To monitor the completeness of the requirements verification activities; this includes monitoring the test protocols (right test conditions,- equipment, -sample sizes, acceptability criteria, etc)
To monitor the execution of the design change control process
To monitor risk management activities according to product risk management plan and compliancy with ISO 14971
To monitor the completeness of the Risk Management file
To monitor the quality of the DHF and DMR documentation .
Quality tasks: This means taking initiatives and providing help by doing.
To make the project quality plan
Create and maintain project–specific quality documentation, such as procedures, work instructions, etc.
To establish a structure for the DHF and DMR documentation
To assist the SPM in creating the product risk management plan and the V&V plan
Supporting the project engineers with defining requirements verification and validation activities
Facilitating change control and risk management activities like Hazard analysis and FMEA sessions
To assist in the requirements traceability and to monitor if the design meets all design input requirements.
To review all verification documentation
Reporting of non-compliances to project manager and quality manager and tracking to closure of corrective actions
To assist in documenting of the milestone review meetings and to ensure proper approval
To assist project members in understanding and applying in the project the requirements of applicable standards (a.o. ISO 13485, IEC62304 )
Archiving and\or transfer of project results after project closure
Performing internal audits within Research
Main experience required
Experience in Research and Research & Development engineering disciplines.
Relevant project experience, understanding the problems in executing project management.
3-5 years experience in QA project and audit activities
Necessary know how / skills
At least Bachelor degree with technical background.
Review and auditing techniques. (ISO 19011)
Measurement and estimations.
Knowledge and experience in CMMi (CMM), TMM
Knowledge of 21 CFR 820 (FDA regulations), IEC62304 and ISO 13485
Proficient in verbal and written English
Required personality characteristics
•Hands on attitude
Team player and easy switch into the different QA roles
Motivator & persuader
Structured way of working.
Er zijn nog geen reacties op deze opdracht.
Je moet inloggen voordat je een reactie kunt plaatsen.