6 MONTH CONTRACT - QA engineer - Cambridge - ISO 13485
URGENT 6 month 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 QA engineer. They are looking for someone who is skilled with ISO13485 and 9001, setting up QMS systems and working with steak holder/ third party suppliers.
You would ensure the control of local CAPA activity, Non-conformances, quality standards and associated document control.
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.
- An engineering or science based degree would be ideal.
- Experience with ISO 13485 and ISO 9001
- Setting up and managing 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 email@example.com, or by calling me on 02079402105 for a discussion in confidence.
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