Quality Engineer Job in Hertfordshire, Home Counties Uk
This is a new role for an outstanding Quality Engineer where you will work closely with the VP, Quality and QA Managers to provide a top class Quality Engineering capability to the business. Focussing particularly on moulded components/packaging and supplier development activities you will establish the specifications and acceptance criteria for new and existing products, together with process improvement activities using statistical/quality tools in compliance with ISO 13485 and FDA (21 CFR) part 820 requirements. With major investment in new technology and products, exciting times lie ahead for business expansion with both existing and new product ranges in this pharmaceutical/medical device manufacturer.
Quality Engineer Duties Responsibilities
- Quality Engineering – including projects, master quality plans, specifications, test methods, supplier performance monitoring and the use of quality engineering statistical tools across production
- New Product Development – over see all activities relating to Design Control and Design History files along with NPD project input
- Vendor Support – audits for key suppliers of moulded components and packaging materials supporting their development activities
- General Quality support – be the CAPA owner and lead investigator ensuring resolution of issues, support quality metrics and audits
- Qualification/Validation support – input into equipment qualification and process validation
- Process Improvement – continuous improvement activities to drive forward efficiency, improve quality and reduce cost
- Team Responsibilities – as a team player, you’ll communicate with cross functional project teams and represent quality at meetings
Quality Engineer requirements
- Graduate Engineer with experience in the medical device industry, plastic moulding and packaging along with supplier development skills
- Outstanding communication abilities where influence, knowledge and an inquisitive mind will leave no stone unturned in the pursuit of excellence
- Demonstrable experience gained in a similar environment covering the full range of quality issues as given above
The Opportunity
If you can bring relevant experience as a Quality Engineer with proven knowledge and an approach that achieves results, then I would like to hear about your successes. Please contact Deborah Blumfield of Hendron Wood Resource Solutions on 01284 700323/07766 562643 for further information and forward your CV using the links.