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Quality Engineer (5 Years Experience, £35k, Medical Equipment Manufacturing, London)

£30000 - £35000
London, United Kingdom
FULL_TIME
2022-08-20
ASAP
54085
4 years 2 months

Job Description

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We have an exciting opportunity for a Quality Engineer role in a Medical Equipment Manufacturing company. The firm is a diverse team of developers, engineers, and medics who develop wearable medical gadgets. It is currently seeking to hire a Quality Engineer with a minimum of 5 years of relevant experience to fit this role. 

Job Requirements:

  • Minimum of 5 years of experience in the Medical Device or IVD business.
  • Working experience in an ISO 13485-compliant environment.
  • Extensive knowledge of the implementation of ISO 14971:2019 in the establishment of Quality procedures.
  • An internal auditor with ISO 13485 training is desirable.

Responsibilities

Job Responsibilities:

 

  • Handle document preparation and routing via the QMS.
  • In charge of change management and record-keeping within the QMS.
  • Determine that all designs and specifications are entered into the QMS, formally authorised, and kept up to date throughout the design procedure.
  • Responsibility for the Training and Competency Process.
  • Responsible for ensuring that all aspects of the QMS get training.
  • Ensures competence is developed for each process and procedure in the QMS.
  • Competency evaluations for all employees must be documented against each area of the QMS, according to the position.
  • Responsibility for providing quality direction to employees in all sectors of the company.
  • Responsible for establishing the equipment testing and preventative maintenance strategy.
  • Monitoring of calibration and preventative maintenance operations, as well as supplier and contract manufacturing locations.
  • Final approval of calibration and preventative maintenance records is required.
  • Where applicable, delegated responsibilities for supplier audit execution.
  • In charge of conducting non-conformance investigations and implementing relevant CA/PA.
  • In charge of implementing the QMS and using risk management approaches.
  • Responsible for maintaining and updating FMEA documentation in collaboration with the Engineering department.
  • Assigned responsibility for Quality authorization within the QMS.
  • Delegated duty for Production Quality Control at the product manufacturing and supplier facilities.
     

Referrals

If you know anyone who may be suitable for the above role, feel free to get in contact with the Mandarin Recruitment team. We will ensure a healthy referral bonus.

About Us

Mandarin Recruitment is a service that helps UK and China businesses & organisations find and source high-quality Mandarin-speaking professionals. We have unparalleled and exclusive channels to the Chinese speaking market, allowing us to be the leading organisation for specialist Mandarin recruitment.

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