MICROBIOLOGY TECHNICAL SPECIALIST - HOME BASED

Posted 6 April by Bosch Global Associates Ltd

TECHNICAL SPECIALIST - MEDICAL DEVICES - UK

JOB TITLE: Product Specialist/Product Expert/QC Manager/Microbiologist.

REPORTS TO: Global Head of Microbiology, Medical Devices.

SALARY: 40-55kGBP.

Bonus: 15%.

Location: Home Based, UK.

REASON: Growth 2017/18.

Travel: The position is home based reporting to the UK office. It will involve travel to the office and third party locations around the globe for business and representative meetings.

Purpose:

The job holder is one of several medical technology managers in the medical devices group. The job holder is a medical device expert responsible for managing activities in the assigned specialist technological area of sterilization and microbiology, ensuring the utilisation of appropriate technical expertise for reviewing medical devices technical documentation and quality systems.

Responsibilities:

The key accountabilities of this role are to:

  • Schedule, plan, perform and report audits of clients’ management systems to ensure compliance with regulatory and voluntary requirements.
  • Assess and report on the sterility assurance aspects of medical device technical documentation and quality systems;
  • Attend assessments as technical expert or provide expert briefing.
  • Review critical data (including sterilization validation), routinely at the cutting edge of technology where no product standards or device experience exists;
  • Identify when additional external expertise is required, make safe recommendations for the issuing of BSI certificates.
  • Deliver Medical Device CE Marking technical review, scheme management and ISO 13485 QMS assessment services as a fully integrated member of the Microbiology Team.
  • Work with other team leaders as required to provide QMS assessment within area of expertise.
  • Provide advice and support to product specialists and scheme managers on certifications.

Qualifications:

  • A degree-level Microbiologist or equivalent biological science
  • Trained and experienced in the routine control and validation of sterilization and microbiological testing (Aseptic fill may be accepted in lieu).
  • A minimum of three years’ experience in the medical device or pharmaceutical field.
  • Hands-on experience of working as a microbiologist in the manufacture of sterile products.
  • Thorough knowledge of Medical Device regulations.

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Required skills

  • Medical Devices
  • Microbiology
  • Quality Assurance
  • Product Certification
  • CE marking

Application question

Do you have at least 5 years microbiology/sterility expertise in medical devices?

Reference: 29887567

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