A leading biotechnology and digital health company is advertising a role for a Quality Assurance Manager to be based in their UK office. The company integrates genetic data into healthcare and provides life-changing answers that transform the lives of individuals, patients, and their families. This position is an exciting opportunity to work with an organisation and provide real expertise in the quality assurance field.
- Managing department reports, including company quality objectives. and communicating these across the company.
- Managing the timely reporting of non-conformities and CAPA Management.
- Reviewing new and existing suppliers.
- Preparing quality assurance documentation.
- Assisting with risk management activities.
- Managing project plans; designing and developing files and medical device files.
- Assisting in internal and external audits.
- Completing technical and regulatory documentation.
Skills and Requirements:
- Bachelor's degree in Science related subject (Biology/ Genetics/ Bioinformatics/ Software preferred) or equivalent work experience.
- Experience of dealing with non-conformities and CAPA management.
- Training within risk management and/or company audits.
- Working knowledge of JIRA, Confluence.
- Experience of CE marking of software.
- Experience of Medical Device files.
- Understanding of In-vitro diagnostic device regulations (IVDD, IVDR, FDA, NMPA).
- Experience of working with ISO 13485 quality management systems.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please Joshua Godden at +44 2038540101 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.