Quality Engineer (Freelance)
The Quality Engineer for Research is accountable for oversight of quality and risk management throughout the pre-productization development phase. The Quality Engineer for Research ensures that products/prototypes are developed in accordance with applicable standards & regulations to facilitate transfer into (clinical) studies or further development and commercialization.
You are responsible for
The task of a Quality Engineer (QE) are:
1. Acts as single point of contact for Research teams to ensure appropriate QMS processes are identified and implemented within the project, including identifying applicable deliverables and ensures that appropriate Quality Plan is created.
2. Provides effective oversight of the execution of early design and risk management activities; including assisting teams in creation of Risk Management deliverables and reviewing or approving documentation
3. Leads Quality related problem solving efforts
4. Makes meaningful contributions to the team in combining the Agile methodology with the Quality System requirements
5. Ensures Quality is embedded within the organization by acting as a champion of best practices and by escalating quality related concerns
6. Collects and reports on Quality related key performance indicators when defined
7. Communicate with Q&R both within Research as well as in the business (where applicable) and escalate to the appropriate level in case non-compliances are not solved.
Must have items
- Master's in engineering degree with > 2 years of experience in regulated industry
- Expert knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering
- Strong team player, open minded, out of the box thinking
- Excellent documentation and communication skills and interpersonal relationship skills including influencing and negotiating
- Working knowledge of standards and regulations applicable to medical software development, including but not limited to IEC62304, ISO13485, ISO14971, FDA QSR, EU MDR
- Must be able to understand and apply risk-based thinking to work queues and projects
- Fluent in English