Job Description
An experienced Quality Engineer is required by Careerwise recruitment to work with our Galway based manufacturing client.
Role of this position
Drive and implement process improvements to ensure predictable processes across all product lines (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.
Job 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.ieCareerWise Recruitment (In Search of Excellence) Established in 1999...
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. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.
#J-18808-Ljbffr