Quality Engineer

TTHE ROLE:

* 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.

* Drive and implement plant wide quality system improvements.

* Drive and implement both the 9001 and 13485 standards.

* Ensure Regulatory compliance in area of responsibility to GMP's of all medical device regulatory agencies (e.g. NSAI, FDA and TUV)

* Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).

* Customer complaints: Approval of analysis reports and analysis of complaint trend

* Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.

* Carry out document control as required.

* Support and drive the implementation of a new Quality software system (QPulse)

* Drive the Corrective Action module in Q Pulse.

* Perform internal quality audits.

REQUIREMENTS:

* 5 years’ experience in a manufacturing/med tech environment.

* Level 7/8 in an Engineering or Quality Discipline.

* Must understand Quality Engineering tools and methodologies.

* Hands-on experience with Lean Manufacturing techniques strongly desired.

* Must be familiar with ISO 9001 and ISO 13485 Standards.

Please call Michael O’Connor today for further information on 091-452410 or email moconnor@careerwise.ie