Job Title: Senior Quality Engineer - Team Leader
Our Client is a large Medical Device company based in Limerick. The Senior Quality Engineer is accountable for quality support for devices, products developed and process design .
•Provide guidance and Quality oversight to ensure establishment and execution of robust design programs aligned with regulatory requirements and industry standards.
•Support new product development and existing product sustaining activities to ensure work follows proper design
control. Ensure controls meet Company and FDA regulatory requirements by actively participating on product development teams and identifying Quality needs, product improvements and customer requirements.
•Manage a team of three
•Report into the US
•Ensures adequate design control documentation and records are maintained to support life cycle of design history.
•Provide support for each aspect of design control and ensure tasks are completed adequately to include project planning, design inputs, critical to quality characteristics, risk analysis, design reviews, validations, verifications, and design history files and other activities as needed.
•Ensures the design is appropriately specified and established before transferring into manufacturing to avoid increased risk.
•Review and authorize Quality approval for new product and/or device design specifications including product performance specifications, test methods, acceptance criteria, and release.
•Support product and/or device shipping studies by providing quality and regulatory requirements, approving protocols, assessing generated data and approving final reports.
•Review and assess work performed by R&D and other business units to help ensure Quality issues with device(s) or component(s) are adequately addressed and when needed corrective actions are taken to prevent recurring quality issues.
•Lead or participate in Risk Management activities appropriate to the initiative or situation.
•Monitor quality data from Product Incident Report process, Manufacturing reports, Service reports and customer input.
•Participate as assigned with supplier capability and internal audits as a means of evaluating effectiveness of GMPs and established Quality Systems.
•A Minimum of 10yrs PQE - 5 years of general process / manufacturing and 5 years of working in a FDA or ISO regulated environment.
•B.S. 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 and GMPs as defined in CFR 820 and of industry standards
•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.
Clodagh Nerney | Tel: +353 (0) 1 507 9254