QA/RA Specialist

Role Overview

We are currently looking for a QA/RA Specialist to join a well established medical device company based in the Harlow, Essex area. As the QA/RA Specialist you will be responsible for

Key Duties and Responsibilities

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the QA/RA Specialist will be varied however the key duties and responsibilities are as follows:

1. Organise and maintain the Quality Management System (QMS) procedure in line with the current quality standards.

2. Review and amend all the Standard Operating Procedures (SOPs), manage all non-conformities and customer complaints and manage CAPA system.

3. Manage competent and regulatory agencies such as MHRA and FDA and make sure the business is audit ready.

4. An excellent understand in the Medical Device Directive (MDD) and Medical Device Regulation (MDR).

Role Requirements

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the QA/RA Specialist we are looking to identify the following on your profile and past history:

1. Proven industry experience in the Medical Device sector and ISO13485.

3. A working knowledge and practical experience with MHRA and FDA Quality standards.

Key Words: QA, Quality Assurance, RA, Regulatory Affairs, 13485, Medical Device