Description
I have an immediate opening for a Quality Engineer (Line Support) with one of the leading medical device companies based in Cork. This is a 12 month fixed term contract role with salary of 50K.This is an excellent opportunity to join a fantastic company on an initial 12 month contract.
Responsibilities:
* Primary Commitment to patient safety and product Quality, and the delivery of key Quality and Performance Objectives.
* Supervision of Quality Technicians.
* Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities)
* Provide effective and responsive QA support to Operations to meet their area's objectives of quality, cost and output.
* Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA's)
* Drive and implement plant wide quality system improvements.
* Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies (e.g. FDA and TUV)
* Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
* Approval of change requests for product, process and quality system changes.
* Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
* Validation: Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
* Compilation of required Regulatory documentation (e.g.Technical files, Design Dossiers, Product transfer files, Essential requirements)
* MRB: Review of MRB trends and identification of appropriate corrective actions when required.
* Perform internal quality audits.
Requirements:
* Ideally will possess Bachelor of Science Degree in Engineering/Technology.
* 3/4 years experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated). * Experience within a Med Device/Pharma environment i.e. FDAISO 9000 necessary.
* Experience/training in problem solving and process improvement methodologies. (Engineering Essentials TM)
* Experience in Class 8 cleanroom environments an advantage
* Experienced in all types of regulated audits an advantage (FDA, Notified Body, Corporate)
* Builds strong relationships by fostering open communications, respect and trust. Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
If you feel you are a good fit for this role and are interested in hearing more about this fantastic opportunity please apply directly to this advert or contact Derek Sheridan on for further information.