Quality Administrator

3 weeks ago

Cambridge, United Kingdom 52 North Health Full time

**We are looking for a Quality Administrator with experience working within ISO13485 or ISO9001 quality management systems**

52 North Health is an ambitious Cambridge-based health tech start-up, whose vision is to improve health outcomes and health equity by reinventing care pathways for all people across the world. Our first product, NeutroCheck®, has the potential to significantly improve quality of life for cancer patients.

Quality is essential in everything we do to:

- keep our users, customers and employees safe,
- satisfy and delight our users and customers, and
- make our business efficient and resilient.

We have recently developed and implemented a quality management system in line with ISO13485 requirements. We are looking for a Quality Administrator to run this system on a day-to-day basis and to take the lead on future QMS improvements and scope expansion. You will work closely with the Head of Product Development and Head of Operations who currently manage the QMS. As a member of a multi-disciplinary start-up team, you will have the opportunity to learn about other parts of the business that fit with your interests and will also be expected to actively contribute to other administrative tasks and activities as required.

We believe that the best work and most exciting innovations happen in open, diverse, and supportive environments, and we strive to create just that at 52 North every day. We love what we do and we trust that you will too

**ROLE SPECIFICATION**

**Responsibilities**
- Administrating all aspects of the quality management system on a day-to-day basis, in particular:

- Approving, auditing and monitoring suppliers
- Managing the document control system
- Training across all QMS policies and procedures
- Organising internal audits and actioning findings from them
- Monitoring QMS performance and identifying and implementing improvements
- Managing Quality Activities (e.g. Change Control, CAPA and Audit actions)
- Supporting scope expansion of the QMS to include manufacturing and post-market surveillance
- Supporting development of policies and procedures to enable the organisation to work toward obtaining other relevant ISO certifications e.g. ISO27001
- Supporting transition to an eQMS platform

**Job type**
- **Part time - 3 days/week**

**Specification**
- Required: _
- A bachelor’s degree and 1 year’s experience working within an ISO13485 or ISO9001 certified quality management system **OR a minimum of** 3 years’ experience working within an ISO13485 or ISO9001 certified quality management system.
- Excellent attention to detail
- Ability to work independently and as a team
- Good computer skills (e.g. Microsoft Office suite)
- Motivated to learn
- Continuous improvement mindset
- Commitment to quality
- Open to occasional travel (e.g. to audit suppliers)
- Proactive
- Desirable: _
- Experience in the medical device industry
- Internal auditor training and experience
- Excellent interpersonal skills
- Desire to develop and take on increasing responsibility
- Enthusiasm for quality and medical device regulations

**Benefits**
- Competitive salary + pension contribution + share options
- Training
- Generous paid annual leave (plus bank holidays)
- Allocated flex leave (to compensate you with leave for the odd occasion you might be asked to work outside of normal hours - which we believe should never be the norm)
- 1 paid annual volunteering day
- Flexible and/or remote working

**Job Type**: Part-time

**Benefits**:

- Company pension
- Flexitime
- Sick pay
- Work from home

Schedule:

- Monday to Friday

Ability to commute/relocate:

- Cambridge, CB3 0GT: reliably commute or plan to relocate before starting work (preferred)

**Education**:

- GCSE or equivalent (required)

**Experience**:

- Quality Management Systems: 1 year (preferred)
- Medical Device Industry: 1 year (preferred)

**Language**:

- English to a professional standard (required)

Work authorisation:

- United Kingdom (required)

Work Location: Hybrid remote in Cambridge, CB3 0GT

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