Opportunity for a Quality Manager to work for a clinical stage combination product company who are working on some novel technology in the aid of the fight against cancer. Being a part of the diverse quality team, this is an opportunity for someone who wants to take control of the suppliers of the device quality for a product that will change breast cancer surgery forever.
- Oversight of device product related suppliers using cGMP best practices.
- Provide cGMP compliance support to manufacturing by investigating and resolving quality issues
- Provide expert guidance to Clinical, Drug, R&D, and other departments regarding quality and cGMP issues to ensure compliance with regulated standards
- Routinely provides quality metrics for management review
- Minimum 5-8 years of experience in the Medical Device industry with knowledge of 21 CFR 820
- Experience with manufacturing in a regulated environment (Medical Device)
- Experience leading supplier audits
- Experience with medical device manufacturing supplier qualification and process validation preferred
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.