Quality Assurance Manager, Oxford, Medical Devices, £40-45k

Job Reference: #43276 Add to saved jobs

  • Location Oxford, Abingdon, Didcot, Newbury, Banbury, Reading, High Wycombe, Swindon, Bicester
  • Permanent
  • Sector Medical Devices

Job Summary

Are you someone who wants to step up and make your own mark on a medical device company’s QMS? This is a great opportunity for an ambitious quality professional looking to take the next step in their career. My client are working with new & exciting technology on a wide portfolio of devices including high risk implantables. Quality Assurance Manager, Oxford, £40-45k, Medical Devices 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.

Job Overview

• Represents Company as Quality Management Representative
• Manage and host customer and notified body / regulatory audits
• Manage CAPA / Complaints system and active contribution to follow up actions
• Manage, plan and perform Internal and Supplier audits to recognised standards e.g. ISO 13485:2016, FDA 21CFR 820.
• Proven ability to design and manage validation activities, including statistical basis supported by DoE design and analysis where required.

Skills Required

• Experience of managing QMS to ISO13485:2016 and medical device development.
• Understanding of MDD 93/42/EEC & MDR 2017/745 and relevant regulations and supporting standards.
• Experience of Risk Assessment & Product / Process FMEA, Control Plans and other QMS procedures.

Contact Details

Full job description and company details are available upon application, apply below. This position is being dealt with by Nathan Berkley at Meet, please call 0203 019 6020. You can also e-mail us directly at nathan@peoplewithchemistry.com to discuss in confidence.

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