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Project manager/ QA engineer contract - ISO 13485 - Cambridge

Employer
NonStop Consulting
Location
Cambridge
Salary
£50 - £68 per hour
Closing date
Sep 19, 2017

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Sector
Science, Life Sciences, Microbiology/Virology
Contract Type
Contract/Freelance
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional

Job Details

Project manager/ QA engineer contract - Cambridge.

An exciting opportunity has arisen within a market leading medical device and diagnostics company.

This is a 6 month contract for a Quality project manager. Your task is to oversee the implementation of a new QMS in line with ISO 13485 - this implantation with be across two sites in Europe. One in the UK and one in the Netherlands. You will spend time at both sites supporting shop floor up to senior management in the process. Once this is complete you will be permanent basis in Cambridgeshire (until completion of the contract).

They are looking for someone who is skilled with ISO 13485 and setting up QMS systems. Also you will need to be very skilled in project management/ coordination (preferably in medical device and also intentionally) in the implementation of new QMS.

What will the role entail?

  • Support CAPA activities from a compliance perspective.
  • Facilitating and leading root cause analysis.
  • Supporting other functions within the business in all aspects of corrective and preventive action activity.
  • Contributing/managing change control activities so that manufacturing team outputs are documented communicated and closed out in full within defined timelines.
  • Managing, developing and implementing business measures which monitor the performance and drive continuous improvement in a cost effect manner to achieve business excellence.
  • Contributing to investigations into adverse quality trends.
  • Participating in Quality training of staff at all levels of the organisation.
  • Actively managing and improving Hull site business measures related to quality dashboard KPI's.

Qualifications:

  • An engineering or science based degree would be ideal.
  • Experience with ISO 13485
  • Implementation QMS
  • Relevant experience in a similar Quality engineering, Compliance or Regulatory related role within a Medical Devices and / or Medicinal Product environment.
  • GMP , FDA and MHRA experience
  • Experience of Quality Assurance within medical device Manufacturing.
  • Proven problem solving tools and techniques experience.
  • Strong influencing and communication skills.
  • SAP knowledge.

This position is based in Cambridge . If this role is of interest to you then do not hesitate to get in contact today as my client is looking to select suitable CV's in the next week. Please send your CV in MS Word format (I am unable to accept PDF copies!) to me directly, Ruby Wallace, at r.wallace@nonstop-recruitment.com, or by calling me on 02079402105 for a discussion in confidence.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
Website

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