QA/QE - Post Market activities (Freelance)
You are responsible for
- Set-up and validate model to define required quality support for R&D projects.
- Drive standardization of QMS processes owned by QA team; e.g. Product Hold process.
- Coordination of Holds within scope of Product Hold process
- Improvement of procedure for FDA Radiation safety Reporting for X-ray Systems
You are a part of
a fast growing and innovative Quality Assurance/Quality Engineering team, within an ever-changing environment - constantly striving for improvements and exceeding internal and external stakeholder expectations.
To succeed in this role, you should have the following skills and experience
- Bachelor degree in technical field; preferably Mechanical, Electrical or Software Engineering.
- 4+ years' experience in medical device industry; preferably in Post Market environment
- Project Management experience
- Experience with post market process like Field corrections and removals, Product Holds.
- Preferably, experience with post market data analytics
- High level understanding of global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, EU-MDR and ISO 14971
- Possess a high-level of self-motivation and ability to work in a team. Ability to effectively manage time, organize and prioritize work, multi-task across many assignments is necessary. Effective interpersonal, written and oral communication skills expected.
- Proficient in standard office computer tools: Microsoft Office, Word, Excel, Project and PowerPoint.
- Excellent English skills, written and speaking.