An experienced Quality Engineer is required by Careerwise recruitment to work with our Galway based manufacturing client.
THE 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
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
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