Quality Assurance Engineer

Candidate Source
West Sussex
26 Nov 2018
10 Dec 2018
Contract Type
Full Time
We are looking to hire an experienced QA Engineer to work closely within the QA and RA Team to improve and maintain the QMS system for a company that produce sophisticated medical equipment / instruments for which the platforms and functionality are regularly reviewed and extended. You will ideally require 3 years Quality Assurance Class IIa/IIb and III, and ISO 13485 experience.

This is a well established business with some great company benefits which are detailed below.
This role is open to non-UK with 2 year visa and UK relocation candidates.

As a Quality Assurance Engineer you will:

- Assist the QA/RA Manager in maintaining and improving the QA/RA functions.
- Manager the maintenance and improvement of the QMS/QSR in accordance with BS EN ISO 13485 & 21 CFR Part 820.
- Streamline the current QMS system to reflect current processes.
- Compile and maintain device technical files and 510K.
- Process change orders through to their completion.
- Assist in the writing and amendment of standard operating procedures.
- Maintain and introduce new modules to the electronic document management system (Entropy).
- Raise and follow up of corrective and preventative action plans.
- Assist and conduct internal and supplier system audits and follow up actions as required.
- Assist the Quality/Regulatory Department in any Notified Body, Competent Authority and regulatory audits.
- Participate in risk assessments in accordance with BS EN ISO 14971 through the use of FMEA analysis.
- Assist and support the R&D department in new projects and transfer to manufacturing.
- Assist and support the manufacturing department in all issues.
- Analyse environmental trends of cleanroom and product bioburden data.
- Facilitate the implementation of Unique Device Identification (UDI)

The ideal Quality Assurance Engineer will have the following skills and experience:

- Degree or equivalent experience in an appropriate academic discipline.
- Quality Assurance Class IIa/IIb & III (preferably active/software Medical Device experience.
- BS EN ISO 13485, 21 CFR Part 820 essential.
- MDD 93/42/EEC, BS EN ISO 14971, EN 62304, IEC 60601, ISO 11135.
- ISO 14644 desirable Experience of auditing desirable.

In return you will receive a salary of up to £40,000 plus the following benefits:

- 27 days holiday plus 8 days public holidays
- Holiday purchase scheme allowing purchase of 5 days additional holiday via salary sacrifice
- Pension 4% matched by employee and employer
- PHI Scheme pays 75% of salary after 6 months long term absence – following probationary period completion
- Death in Service Scheme pays 4 times salary – following probationary period completion.

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