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Job Details

Quality Assurance Manager, Cambridgeshire, £50-60k, IVDs

Company: Meet
Location: Cambridge, Ely, Bury St Edmunds, Peterborough
Reference: NB-QM-CAMB
Closing Date: 28 Feb 18
Type: Permanent
Salary (£): 40,000 - 60,000
Benefits:

Job Summary:

The QA Manager for this growing, well-funded Diagnostics company will be responsible for documenting and maintaining a Quality Management System. They will maintain its effectiveness in accordance with the requirements of relevant international standards as well as providing regulatory input into the Product Development process and CE marking submissions.

Requirements:

QA Manager, IVDs, Cambridge, £50-60k

Please contact Nathan Berkley on 0203 019 6020 or email nathan@peoplewithchemistry.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

Overview of Key Duties and Responsibilities

  • Achieve and maintain ISO13485 certification for the organisation.
  • Support the Product Development Group and provide input in the Product Development Process where required from a Quality and Regulatory perspective and in the creation of technical files.
  • Maintain the quality management system. Manage the day to day aspect of document control and issuance of training records related to QA, manage the training matrix reflecting and identify gaps in training per operator role. Work with team leaders to advise on required training and deliver training on quality SOPs.
  • Conduct spot checks and internal quality audits regularly and in a supportive constructive manner, coordinate a review of the results and ensure corrective actions are agreed and implemented in the timescales set.

Key Skill Required:

  • Quality experience within the IVD industry
  • At least 3 years’ experience within an ISO 13485 environment
  • Knowledge of the Medical Device Directive 93/42/EEC and experience creating and maintaining CE technical file
  • Experience in product development and creating design history files

Please contact Nathan Berkley on 0203 019 6020 or email nathan@peoplewithchemistry.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

Meet are good people who are great at recruitment. We’re proud to partner with the industry’s leading Pharmaceutical, Biotechnology, Medical Device, Marketing Communications and Contract Research Organisations (CROs) worldwide, helping them to find and secure the best global talent available.  We pride ourselves on our open, friendly approach and are here to guide you through the recruitment process every step of the way.

Find out more about us at www.peoplewithchemistry.com and https://www.linkedin.com/in/nathan-berkley-a25811139/

Key Words

Medical Devices, IVD, Diagnostic, Senior Quality Associate, Quality Assurance, Quality Assurance Officer Jobs, Medical Device Jobs, QA Associate, QA/RA Associate, Quality Assurance Associate Jobs, Quality Assurance Associate, Quality Assurance Officer, Quality Assurance Manager, Quality Assurance/Regulatory Affairs Manager, QA/RA Manager, Medical Device, Cambridge, Luton, Ely, Northampton, Bedford, Milton Keynes

Apply for this job: Quality Assurance Manager, Cambridgeshire, £50-60k, IVDs

Contact Information:

Address:  meet
Irongate House, 30 Dukes Place, London
EC3A 7HX
England
Tel:  +44 203 178 7488
Website:  Visit Our Web Site

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