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.
- 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.
If this sounds like your new challenge or new job, don’t hesitate! and contact us via: email@example.com.