Quality Assurance Specialist

What are you going to do?

As the QA Specialist you will be responsible for maintaining and improving  the QMS document control system including the documentation for private label product production.            

You will proactively support operational staff to comply with the QA requirements. You will be our gatekeeper in risk management, vigilance processes and complaint management.

Update procedures for self-certification for class I medical devices and certification in cooperation with the Notified body. Monitoring external changes to the related standards and assess impact for Medeco B.V. is also a main aspect of the job.

You will be responsible for the timely execution and follow up of internal and external audits, following the Medeco B.V. quality system.  

What is your background?

• Minimal bachelor degree or a master's degree with focus on Quality
• Minimum of one year experience as QA Officer in Manufacturing processes (chemical, medical or food)
• Knowledge and expertise of quality systems and their certification dynamics. Trend monitoring, and reporting for compliance
• Knowledgeable regulations and standards like ISO13485, ISO 9001, ISO14971, MDR and GDP
• Must have a proven track record of the ability to influence at different levels
• Have agility and pro-active skills