QA Specialist

I'm working exclusively with my medtech client in the Overijssel region of the Netherlands, and they are in need of a QA Specialist/Engineer to support their teams due to a gap in the team. You will coordinate with internal and external stakeholders to align projects with the QMS and Quality Plan, and will be the key POC from a QA perspective. Initial contract 6 months, with chance of extension thereafter. 
 
Role:

• Coordinate with internal PMs/Team Leads and the QA teams of the customers regarding the QA requirements on a daily/weekly basis
• Ensure the teams understand the requests and check the company QMS is compliant with the requirements for the projects. If there are gaps, remediate them and align the QA plan accordingly
• Work with the R&D teams to review the projects on a weeks basis, and ensure they are aligned with the QA plan. You will sign off from QA perspective where required.
• On vs off site: Hybrid is possible with 2-3 days per week on-site being the preference.

Skills:

• Strong QA Background in the Medtech sector with ISO13485 expertise
• Good understanding of medical device development and ideally also have expertise with FDA 510K submissions/21CFR (nice to have, not hard requirement)
• Another “nice to have” is expertise with supplier management/selection
• Languages: English  

Interview process: 1 stage interview process via Teams this week and next

Interested? Send your CV to c.girdwood@panda-int.com