Senior Design Assurance Engineer
Our client, a medical device company in Limerick is currently looking to recruit a Regulatory Affairs Specialist for their site.
The Senior Design Assurance Engineer is accountable for supporting the Research Center 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 Sr. 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 BD best practices.
Be the Difference in Quality Engineering
The Sr. Quality Engineer is accountable for supporting the Research Center 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 Sr. 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 BD best practices.
The Senior Quality Engineer is accountable for quality support for products developed and process design to achieve these goals through active participation and contribution to multifunctional and multi-divisional teams. The Sr. Quality Engineer is responsible for assuring that quality standards and regulatory compliance activities are consistent with Corporate/Division Policies, Government Regulations, International Standards and standards broadly recognized by the Medical Device Industry.
The position requires a self-motivated, self-directed individual able to handle multiple projects across multiple business units and tasks utilizing a high level of written and oral communication skills. In addition the incumbent will be expected to initiate quality initiative projects, become thoroughly knowledgeable with all aspects of quality engineering and new product development and assumes personal responsibility for the successful completion of all tasks within the realm of quality engineering responsibilities. The Sr. Quality Engineer reports to the Quality Manager, RCI.
Be the Senior Design Assurance Engineer
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.
SW/HW Development Guidance
· 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:
o Risk Management Plan
o Risk Analysis
o Risk Management Report
General Guidance for Project/New Employee Onboarding
· Accessing C2C training/understanding MMS training requirements
· Accessing SAP
· Accessing TFS
· Accessing Sharepoints
· Create Receiving and material handling SOPs
· Temperature Records Management (e.g. temp charts, OOS, etc.)
· OOS SOP/Investigation management
Lab Equipment Controls
· 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.
· A minimum of 5 years of experience working within a quality function.
· A minimum of 5 years of experience working in a FDA or ISO regulated environment.
· A minimum of a bachelor’s degree is required.
· 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 Regulatory Affairs Specialist role in Limerick please contact Bimi Felix on 086 8395533 / email@example.com
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