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.