QA/RA OFFICER Medical Devices IVD

ROBERT WHITE is currently looking for an experienced QA/RA Officer with extensive experience in the In Vitro Diagnotisc devices industry (IVD). Our client is a global leader in workflow solutions and automation, integrating each step in the workflow from biopsy to diagnosis with global presence.

POSITION:

• Responsible for maintaining daily Quality operations in compliance with applicable regulatory requirements and standards and our clients requirements
• Support QMS conversion to IVDR as per determined LBS-AMS IVDR implementation plan
• Work closely with QRA team and all site functions to support all activities related to IVDR transition
• Chair CAPA, NC and CC Review Boards
• Responsible for the site Compliance Plan, Management Review and KPI reporting,
• Support / Lead the Internal Audit Program by creating / maintaining audit schedules for the current QMS as well as for IVDR-compliant QMS.
• Mentor junior staff and provide education/ trainings to other functions on regulations and Quality System designed as per IVDR, ISO 13485, CFR 21 Part 820
• Host regulatory, for our client and customer audits; monitor and improve audit readiness; ensure backroom preparations.
• Support and develop working relationships with cross functional teams including R&D, Manufacturing, Procurement, Logistics and Product Management to ensure process solutions are compliant to applicable regulatory requirements and the company QMS.
• Support preparation of the Quality System Management Review; deputize for chairing Management Review meeting.
• Interact with global Quality counterparts within ASI and LBS to ensure benchmarking with the best Quality System processes.
• Maintain and develop working knowledge of relevant regulations and Quality System requirements that impact the business
• Use our clients Business System tools to continually improve the Quality Management System
• Other duties as assigned by Sr QRA Manager and as required to maintain successful continuous operation of business

WHO ARE YOU?

• Bachelor’s degree in science, medical or technical field and 5+ year experience with increasing responsibility in IVD and/or Medical Device or Pharma industry in QA and/or QC functions
• Graduate degree in science, medical or technical field and 3+ years experience with increasing responsibility in IVD and/or medical device or pharma industry in QA and/or QC functions
• Full professional proficiency in English
• Highly desirable – advanced knowledge of the new EU device regulations – IVDR and/or MDR
• Desirable – experience of working in the laboratory and/or QC laboratory
• Experience in the IVD industry is preferred
• Formal certification in auditing to ISO13485 and regulatory requirements for EU and USA is preferred
• Desirable: Previous experience in using Danaher Business System (DBS) tools
• Demonstrated success performing a wide range of Quality System related activities as listed above in Major Responsibilities section. 
• Strong organizational and analytical thinking skills.
• Ability to multitask
• Strong writing skills and ability to use appropriate software tools to develop and edit documents, procedures, reports. 
• Exceptional communication skills (verbal/written/presentation/relationship building)
• High level of initiative, self-motivation and energy.

INTERESTED?

If this sounds like your new challenge or new job, don’t hesitate! and contact us via: info@robertwhite.nl.