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You will oversee daily operations ensuring compliance with ISO13485 & GMP regulations at all times. You will work closely with internal and external stakeholders / partners to deliver high quality production whilst driving improvements to operational efficiency and cost.
Client Details
The client are a small med-tech organisation developing novel implantables. They are currently undergoing clinical trials and seeking a dynamic Head of Operations to bolster their team.
Description
As a Head of Ops you will:
- Hold overarching responsibility for operations striving for high-quality, efficient production for clinical trials in line with ISO13485 & GMP regulations
- Identify process improvements with the aim of establishing more robust, efficient processes whilst maintaining quality
- Lead design transfer processes for new products from R&D phase into manufacturing
- Manage key supplier relationships and work closely with external providers to derive new packaging configurations
- Provide technical leadership and foster a culture of continuous improvement
This role is predominantly site based, and will have initially one direct report.
Profile
To be successful you will have:
- BSc or MSc in relatable field (Biomedical Engineering, Engineering or related)
- Strong expertise and knowledge of class III medical devices and associate regulatory landscape
- First hand experience of design transfer, validation and working with external stakeholders
- Significant experience in a senior operations role within medical devices
- A dynamic attitude with the ability to adapt to new challenges at pace
Job Offer
This is fantastic opportunity to join a dynamic and growing med tech organisation developing novel implantable class III medical devices. you will be influential in the operation and support in nurturing a culture of continuous improvement and integrity.
