I am keen to speak with established Quality Engineers with a background in New Product Introduction Projects within a Regulated Manufacturing Environment.
The suitable candidate should have a working knowledge of Design Controls, Design and Process Validation, Process Risk Management, be able to provide Quality Engineering support for New Product Development (NPD) projects and change controls.
Working in Cross-Functional Teams this challenging role offers numerous Engineering Projects which will challenge you daily – APPLY TODAY
QA Engineer / Quality Assurance / Quality Lead / QA / NPI / Design Assurance / Global Quality Strategy / Process Validation / Medical Device Manufacturing / Mayo / Ireland
ISS Ltd Recruitment Agency will also be offering a Relocation Package (€) for Engineers who need to move to County Mayo, and this is open to Irish, UK & EU Citizens.
Job Title: Quality Engineer – QA Program Lead
Location: Co. Mayo
- Full Time / Perm
- €65k – €70k Basic
- Annual Bonus
- Health Insurance
- Paid Annual Leave
The purpose of the position is to represent Quality Assurance on the New Product Introduction Team. Projects will include supporting the qualification of new equipment and up-grades to existing equipment. In addition, you will support the delivery of Global Quality Strategy at the County Mayo site.
- QA oversight of NPI program through to Production and ramp up of production
- Represent QA at NPI program meeting eg/ QA program update 4-square
- Submit QA update on NPI for Global Quality Regulatory and Clinical monthly meeting
- Understand interdependencies across projects and sites
- Understand & compile a list of QA risks across each project/site
- Work with risk owners on mitigation plan to understand action, timeline, impact to overall project
- Co-ordinate (as required) cross site/program actions
- Initial Point of contact for project Design Assurance/QA and Site Functional Managers for escalation of NPI related quality issues
- Program Lead for delivery of Global Quality Strategy at the county mayo site
- Complete internal audits per the audit schedule
- Complete CAPA investigations
- Lead Production System audits for the department
- Degree in Engineering/Science Discipline
- 8 Years’ experience in Medical Device Industry utilizing Automated Equipment
- Experience in statistical analysis / SPC / validation of automated equipment
- Communication: Excellent communication and presentations skills, both written and oral – ability to present forecasting, capacity, and other relevant Quality data in a clear and concise manner to the Business Unit Planners and where required, to senior management
- Planning & Organising: Able to plan activities and tasks
- Decision Making: Identify and understand issues, problems and opportunities whilst providing a viable solution
- Adaptability: Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints
- Passion for Results: Drive, high energy, maturity, and ability to work under pressure and deliver results; get things done (an action-oriented approach); overcome obstacles
If you would like to be considered for this opportunity why not contact me directly on my mobile (See Profile); Just ask for Patrick.
Alternatively follow the links below and send me your CV.
Key Words: QA Engineer / Quality Assurance / Quality Lead / QA / NPI / Design Assurance / Global Quality Strategy / Process Validation / Medical Device Manufacturing / Mayo / Ireland
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