Quality Assurance Specialist - Medical Devices - Cambridge

G2 Clinical & Professional Resourcing
£35,000 - £40,000
13 Nov 2017
16 Nov 2017
Contract Type
Full Time
Job Title: Quality Assurance Specialist - Medical Devices - Cambridge

Salary + OTE: £35,000 - £40,000 + benefits

Location: Cambridge area

Medical Device experience essential

The Role

- Working for an innovative and growing medical device start up business as a Quality Assurance Specialist
- Your main responsibilities will be to assist with the R&D team managing the QMS on a daily basis
- You will help with the overall product creation process, working closely across all functions in the business including marketing, operations and product development
- You will also help with the administration of quality documents, internal and supplier auditing and third party manufacturers
- You will also be involved in developing specifications, refining requirements and value engineering. You will take a lead role in all risk based analysis stages i.e. FMEA, fault tree analysis etc.
- As a member of the technical team you will be encouraged to participate in company meetings and conference calls where your opinion will be heard and valued

The Candidate

- We are looking for QA professional with experience within medical device, or biotechnology field.
- Minimum 3 years' experience including a quality engineering role
- "Hands-on" approach to understanding and solving engineering problems
- Knowledge of Medical Devices Directive / FDA cGMP / ISO 13485
- Ability to lead CAPA, change control and quality issues across the organisation
- Lead internal and external audits
- ISO 14971

The Company

- Innovative and cutting edge technology
- Start up phase - opportunity to join at the ground floor
- Progression opportunity
- Dynamic and forward thinking company

G2 Clinical and Professional Resourcing are specialist recruiters for a wide range of positions including R&D, Quality, Compliance, Regulatory Affairs, Project Management, Manufacturing and Senior Operational positions.