Quality Assurance Technician (QMS, ISO13485, Medical, FDA)

SJB Technical Recruitment Ltd
To £26k
19 Oct 2016
18 Nov 2016
Contract Type
Quality Assurance Technician (QMS, ISO13485, Medical, FDA)

Coventry, West Midlands

To £26k

Our client is a leading supplier of products to the medical devices advanced wound care market, developing fibres and fabrics for products that greatly improve patient outcome.

The Quality Assurance Officer / Technician will be responsible for supporting the Quality Management System within the business ensuring compliance to ISO 13485 and FDA standards. The key purpose of the role will be to work closely with the Quality Assurance Manager and Quality Assurance department to develop and deliver a range of proactive and responsive QMS initiatives.


- Ensure compliance to standards, regulations and internal procedures by proactively interpreting quality and regulatory requirements and implementing solutions
- Support quality related projects
- Prepare quality documentation by collecting, analysing and summarising information and trends including audit findings, non-conformances, customer complaints, corrective and preventive actions
- Manage and perform internal audits, along with management and implementation of corrective actions
- Administration of electronic document control system, contributing to the drafting of documentation, approval, reviewing and implementation of internal QMS documentation in accordance with ISO13485, FDA CFR 820 part 21 and MDD
- Co-ordinate change control activities
- Co-ordinate equipment calibration/maintenance activities
- Provide training relating to the quality management system to all levels of staff within the business
- Administration of electronic CAPA system database, co-ordination and investigation of non-conformances and management and implementation of corrective and preventive actions
- Work within the Quality department to promote continuous improvement and ensure compliance with quality policies across the business
- Co-ordinate Quality System validation activities

Compliance responsibilities

- Act as a Lead Auditor once training has been completed

Key skills / abilities

- Quality Assurance experience
- Strong working knowledge and experience of applying ISO 13485, FDA 820 part 21 and MDD standards and regulations within the Medical Device or IVD industries is essential
- Experience of participation in internal and/or external audits
- Clean room and GMP knowledge / experience
- Able to get on with and influence people both internally and externally to achieve objectives
- Able to work with minimum supervision and as part of a team
- Strong communication skills both verbal and written, flexible attitude and capable of working under pressure to tight and constantly changing deadline