Quality Assurance Engineer - Aylesbury, United Kingdom - Owen Daniels Consultancy

Owen Daniels Consultancy

Verified Company

Aylesbury, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Quality Assurance Manager

Permanent

£40,000 - £50,000 per annum

8am - 5pm or 9am - 6pm Monday to Friday

Aylesbury
- ****Quality Assurance Manager

Job Description**:

Monitor supplier quality performance, including inspection, nonconformities, production permits, identifying route cause and drive improvement in operations by leading problemsolving meetings;
Communicate effectively the requirements of Quality Management System;
Conduct Quality Audits (product / product release / process / Supplier Quality / Supplier acceptance);
Ensure effective & timely closure of actions received from Audit Non Conformities/internal Non Conformities/customer complaints;
Management of Root Cause Corrective action to ensure timely, effective closure;
Participation at design reviews and performing First Article Reviews (FAR's) ( Internal & Supplier);
Evaluation of product development, performance of peer reviews of work products to support implementation of program(s) lifecycles and processes (test Software, Firmware, Hardware & Systems);
Maintain quality records (including but not limited to Customer Comments, Change Requests, Post Market Surveillance, Non-Conformance Reports);
Ensuring integrity of products, materials and processes to satisfy business, customer and regulatory requirements;
Generation, review and maintenance of Quality /Supplier Quality/ Configuration Management Plans;
Application of quality tools and techniques to facilitate the monitoring, reporting and resolution of quality issues;
Application of risk management techniques to assess, mitigate and prevent potential product quality issues.

Quality Manger/Engineer

Essential Skills/Experience/Qualifications:

Bachelor's degree or equivalent experience in an Engineering / Quality Assurance discipline
A minimum of 2 years' experience of working with Medical Device regulations or within a heavily regulated, equivalent industry
Previous experience completing audits with Certification Bodies
Has the understanding and ability to perform complex Root Cause, Preventative Counter Measure and Corrective Action implementation methods
Previous experience conducting supplier assessments

Quality Manager /Engineer

Desirable Skills/Experience/Qualifications: