Our client, a medical device company in Limerick are currently looking to recruit a Quality Engineer for their site.
The Quality Engineer is accountable for supporting the Research Centre Ireland (RCI) site, RCI Project teams and/or other projects intended to enhance RCI’s operational effectiveness including the initial creation of a Quality Management System for the RCI site. The Quality Engineer focuses on the creation of quality processes and procedures at the RCI site which support design control, process control & validation, supplier management and technology transfer based on industry and the company’s best practices.
The Ideal Candidate
Quality Systems development
- Begin to develop Quality system to support design activities
- Provides guidance and Quality oversight to ensure establishment and execution of sustaining programs aligned with regulatory requirements and industry standards.
- Support new product development activities to ensure work follows proper design control. Ensure controls meet BD and FDA regulatory requirements by actively participating on product development.
- Guides the successful completion of major programs and may function in a project leadership role.
- Help Facilitate Document review and approval with Medication Management System (MMS) BU.
- Assist with Test Case Reviews.
- Review and approval of Verification and Validation plans/protocols/reports.
- Develop Test Method Validation documents.
- Facilitating and coordinating the risk management process.
- Responsible for leading the Risk Management Team in determining if new risk management documents will have to be created or if existing product family risk management documents will be updated.
- Develop the following risk management documents:
- Risk Management Plan
- Risk Analysis
- Risk Management Report
- General Guidance for Project/New Employee On boarding
- Accessing C2C training/understanding MMS training requirements
- Accessing SAP
- Accessing TFS
- Accessing SharePoint
- Test Instrument
- Create Receiving and material handling SOP
- Temperature Records Management (e.g. temp charts, OOS, etc.)
- OOS SOP/Investigation management
- Calibration/PM – Managing, reviewing/approving/OOS investigations
- Blue Mountain RAM Access/Management (Data entry)
- IQ/OQ review/approval
- Liaison with Field Service Engineers to ensure proper documentation of servicing
- Technology Development Understanding/Guidance
- Help project teams understand process and requirements
- Provides guidance to team and application of Design Controls 21CFR 820.30 for new product development.
- Creates and supports documentation.
- 2 years of experience working within a quality function.
- 2 years of experience working in a FDA or ISO regulated environment
- BS Degree in scientific discipline: Engineering, Chemistry, Biochemistry or related science
Certified Quality Engineering (CQE) preferred.
- Robust understanding of QSR, Design Control, ISO, Product Risk Management (ISO 14971) and GMPs as defined in CFR 820 and of industry standards but not limited to Green belt and Design for Six Sigma methodology and tools.
- Excellent people interaction, team building, and communication skills. Problem solving skills with experience in project management to include organization, prioritization, problem solving, and sound judgment are critical. Understanding of statistical analysis expected.
For further information on this Quality Engineer role in Limerick please contact Orla on 086 0449473/ email@example.com
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