QA Associate

Location: West Sussex  |  West Sussex  |  England
Sector: Life Sciences
Consultant: Chris Hutchinson
Job Reference: HQCHQAA
Salary: £30000 - £45000
Job Status: Permanent / Full Time

QA Associate 

I am seeking a QA Associate to ensure that business continually meets all quality assurance requirements as defined in ISO 13485:2016, 21 CFR 820, the Medical Devices Directive 93/42/EEC and 98/79/EC In Vitro Diagnostic Medical Devices

Also you would be working with QA/RA Manager to ensure that all complaints and vigilance reporting requirements are carried out in accordance with the MDD 93/42/EEC and relevant guidance documents

REQUIRED COMPETENCIES

Excellent understanding of European Medical Device Directive requirements

Knowledgeable of:  ISO 13485, 21 CFR Part 820, CMDCAS.

Be self-motivated and able to work independently or as part of a team

Experience of managing Quality teams.

Certified/Training internal auditor to ISO 13485

Experience working with class I, IIa and IIb Medical Devices.

Pragmatic, enjoying a mix of activities in technology, business processes, regulatory affairs.

Communicative and service oriented

Strong organizational skills, detailed oriented

Experience with FDA 21 CFR 820

Experience with ISO 14971 Risk Management 

This position is offering from £30,000 up to £45,000 depending experience.

If you are interested in this please get in touch and send your CV, we are looking to interview candidates as soon as possible.