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TECHNICAL OPERATIONS MANAGER - Med Device

Job Title: TECHNICAL OPERATIONS MANAGER - Med Device
Contract Type: Permanent
Location: West Yorkshire, England
Industry:
Salary: £30000 - £50000 per annum
Start Date: ASAP
Reference: J907300_1610965853
Contact Name: Ben George
Contact Email: ben.george@russell-taylor.co.uk
Job Published: January 18, 2021 10:30

Job Description

Role: Technical Operations Manager

Location: West Yorkshire

Salary: Competitive

Russell Taylor Group has a fantastic opportunity for a Technical Operations Manager to join a Medical Device Company in North Yorkshire. Oversee all validation, biocompatibility and microbiology activities in the company, ensuring production processes, equipment and final product meet regulatory requirements.

Role:

  • Take overall responsibility for microbiology including product cleanliness and sterility. Ensure the processes for cleaning, sterilisation and testing are validated. Author and approve reports as necessary.
  • Undertake biocompatibility activities for raw materials and finished products. Ensure suitable testing is carried out and biological evaluation reports produced.
  • Be responsible for validation and microbiological activities at the company, including the manufacturing environment, clean room, packaging, shelf-life studies and changes to materials or processes.
  • Be responsible for the Validation Master Plan including monitoring and reporting the status of all current and new validation requirements.
  • Implement the Risk Management procedure and maintain RM and pFMEA files.
  • Provide technical support for equipment qualification and computer systems validation.
  • Undertake relevant technical aspects of investigations following internal incidents or complaints.
  • Review and approve COSHH assessments and any other technical documentation as required.
  • Act as a Continuous Improvement champion to encourage a culture of identifying problems and collaborating to develop solutions that increase efficiency and eliminate waste.
  • Set SMART objectives for team members. Provide the opportunity for regular catchups, giving feedback and coaching as required. Conduct Staff Development Reviews at least once a year.
  • Any other duties as may be requested by the Operations Director.

Essential Experience, Knowledge and Qualifications

  • Degree in a relevant scientific subject, such as chemistry or biology.
  • Experience in aspects of Quality in a medical device company.
  • Scientific experience in a medical device company.
  • Line Management experience.
  • ISO 10993 Biological Evaluation of Medical Devices.
  • ISO 13485

Person:

  • Higher degree in a scientific subject.
  • Microbiology experience.
  • Familiarity with sterilisation standards such as ISO 11737 and 11137.
  • Able to provide scientific support to team members at all levels and assist in decision making.
  • Self-motivated with a proactive approach to the role and a creative attitude to problem solving.
  • Able to meet multiple deadlines with a personal commitment to quality and attention to detail.
  • Able to successfully lead a team and work with others across the company.
  • Good written and verbal communicator.

Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy h t t p s : / / w w w . r u s s e l l - t a y l o r . c o . u k / p r i v a c y - p o l i c y on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or the GDPR please contact us on h r @ r u s s e l l - t a y l o r . c o . u k