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Quality Assurance Specialist - Temp 6 month

CooperSurgical

Education
Benefits

CooperSurgical Fertility Solutions is the global leader in IVF and reproductive genetics, providing innovative products, services, and training for every step in the ART journey. 

Healthy women, babies, and families™

At CooperSurgical we are currently looking to recruit an Experienced QA specialist for a 6-month temp contract. You will be part of the CooperSurgical Global Quality team, with direct reference to Sr. QA Engineer placed in US. This role is placed in UK and on -site, White City- London.

Position

In the role as Experienced QA specialist, you will drive part of a project that should ensure accreditation in accordance with CAP LAP and NYS CLEP. You will need to communicate and explain the requirements to the Genomics Lab staff in the UK. At the same time, you will need to assess the QMS and conduct a thorough gap analyses, identify shortcomings and ensure the findings are being solved and implemented within the timeline. You have solid knowledge of quality management, and preferably you have familiarity with US regulations (State and Federal).

You thrive in a dynamic environment and are comfortable juggling several complex tasks while keeping an eye on the details. You will work closely together with the Quality and Regulatory teams and relevant stakeholders, globally. 

  • Update QMS to meet US State and Federal Regulations 
  • Perform gap and risk analyses 
  • Align communication and timelines
  • Conduct Audit to achieve site accreditation 
  • MSc in Science
  • + 8 years of experience from a similar role, preferable within ISO 13485 and ISO 15189
  • +4-5 years managing a Quality management system
  • Experience with an international set-up
  • Problem-solving, structured, and systematic approach 
  • Good communicator and team player
  • Robust and flexible mindset
  • Proficient level in MS office
  • Fluent English (spoken and written) is mandatory
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Confirmed 13 hours ago. Posted 30+ days ago.

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