Role: Technical Manager - Operations - Biocompatibility
Location: West Yorkshire
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.
- 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
- 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.