|Job title :||Quality Engineer|
|Contract type :||Permanent|
|Location :||Waterford, Republic of Ireland|
|Salary :||€45000 - €55000 per annum|
|Start date :||ASAP|
|Job Reference :||SYN2413_1617704412|
|Contact name :||Zac Pyne|
|Contact email :||firstname.lastname@example.org|
- South East of Ireland
- 39 hours per week
- Accommodation available
- ISO13485 & CFR part 820
We are currently recruiting for an experienced Quality Engineer for our Medical Device Manufacturing client located in the South East of Ireland. The successful applicant will quickly become an integral part of the business in ensuring that manufactured products meet company quality specifications, designing inspection sheets, troubleshooting quality issues and generally assisting all departments with ISO & AS compliance. You will naturally be involved with investigations into non-conformance, internal audits and preparing SOP's.
The Job Role
Key duties /responsibilities:
Responsible for the cleanroom facility management (qualification/maintenance/ extensions) including HVAC and supportive utilities within a GMP compliant Quality Management System
Support NPI team in the execution of Performance Qualification (PQ) for clean room processes as per the project schedule
Responsible for planning and execution of Periodic Review and Revalidation activities for clean utilities, systems and equipment.
Maintains and implements environmental controls
Support deviation investigations throughout the facility
Serve as a subject-matter expert on validation activities during regulatory agency inspections
Participate in risk assessments, inspections, audits, incident investigations, etc.
Create concise and accurate on-time technical reports. Clearly communicate results internally and to customer using quality tools and statistical techniques
SME for appropriate statistical techniques to monitor process performance (e.g. SPC, Cp, Cpk, R&R analysis, sampling techniques and other statistical techniques)
Acts as the customer conduit for all quality related issues, capable of articulating complex technical solutions to customers in a manner that's easily understood.
Creates and evaluates metrics to drive tangible quality improvement.
Evaluate materials, gather and analyse data and determine root cause of problems using relevant corrective action systems (e.g. CAPA / 8D / A3 Problem Solving)
Experience and skills:
5+ years in a similar role (ISO and/or AS)
· Internal Auditing experience
· Non-conformance & SOP experience
· GMP experience essential
ISO 9001-13485 CFR 820 Knowledge essential
· GMP (good manufacturing practice) experience
· ISO 9001-13485 CFR 820
· 5why, 5s, NCR, CAPA
We will endeavour to respond to all applicants, but if you do not receive a response within 5 working days, please consider yourself unsuccessful on this application.
Syntech Recruitment Limited is acting as an Employment agency in relation to this position.