Senior Quality Engineer
Bd Medical
Limerick
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. 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 Development Guidance – support lab automation activities Help Facilitate Document review and approval with Diagnostic Systems BU. Assist with Test Case Reviews. General Guidance for Project/New Employee Onboarding Accessing C2C training/understanding DS training requirements. Accessing SAP. Accessing TFS. Accessing Sharepoints. Test Instrument Consumables/Reagent Control 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. Help facilitate technology integration (i.e. transfer to GPDS. Provides guidance to team and application of Design Controls 21CFR 820.30 for new product development. Creates and supports documentation. This job originally appeared on RecruitIreland.com.
2041 days ago