Quality Specialist
2 weeks ago
Biofidelity is a revolutionary genomic technology company dedicated to unleashing the potential of genomics to transform human health and the world we live in. Our adaptive platform technology removes the noise from genomic data, providing only the information needed to make decision making less complex, faster, and more accurate.
At Biofidelity we are proud to have built a culture of humanity, openness and high expectations. We work towards well-defined goals, with a strong belief that we can make genomics globally accessible. Our people are keen to take responsibility for their work and share both their successes and challenges.
Alongside a competitive salary and opportunities for career development, we offer a comprehensive benefits package including private medical & dental care, bonus, share option scheme, pension, income protection and life insurance, cycle to work scheme, season ticket loan, 26 days per year holiday allowance and free physical training sessions.
**The role**
Biofidelity is seeking an experienced and efficient Quality Specialist to support with the implementation, maintenance and continual improvement of their Quality Management System. The position will work closely with staff to promote a quality culture and ensure understanding of Quality Systems. This position reports to the Director of Quality/Executive Director of Operations.
**Key responsibilities**:
- Ensure implementation and maintenance of the company’s Quality Management System
- Supporting the Product Development team in the creation and maintenance of product development documentation (Medical Device/Technical Files), including risk management activities
- Supporting the Director of Quality with regulatory activities including audits and preparation of technical documentation
- Promote the development of a 'Quality Culture'
**Knowledge, Skills, and Abilities**:
- Experienced in many elements of ISO 13485:2016 and used to having responsibility for specific areas i.e. document control, internal audits, validation and product development
- Experience in compilation of design history files, medical device files etc (desired)
- Experienced in use of electronic document management systems and other software
- Experience in ISO 14971 Risk Management, and facilitating risk management exercises i.e. FMEA and subsequent reporting
- Trained ISO 13485:2016 internal auditor. Proven experience of supplier auditing and evaluations is also preferable.
- Excellent organisational and communication skills
- Ability to manage multiple tasks to deadlines, think on your feet to solve problems and maintain a high level of accuracy, even in a changeable work environment
**Requisite Education and Experience / Minimum Qualifications**:
- Degree in science, medical or technical field
- Minimum of 3 years proven experience, working in quality, under a ISO 13485:2016 quality management system. Experience of working with _in vitro_ diagnostic devices is preferred.
- ISO 13485:2016 internal auditor
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