Product Quality & Quality Assurance Engineer
Product Quality & Quality Assurance Engineer - Galway. In this role you will be responsible for the ongoing management & development of product manufacturing & quality programs with the company's sub-contract manufacturing partners for new and existing products, ensuring that the internal quality system for process and product controls is in compliance with ISO 13485 and FDA Quality System Regulations. This role will also support the implementation and improvement of the Quality Management system. Core duties will include: Implementation and oversight of Supplier Quality Management plans / agreements, including review, supplier audits, issue resolution and scorecard based supplier performance management. Development and maintenance of Quality Management programs aimed at optimising process and product quality with sub-contractors and other suppliers, including supplier visits as needed. Provide technical & quality support during transfer of products and associated technology from design to sub-contractors including PQP development / process qualification & validation, and production support including qualification. Support customer complaints process with specific responsibility for product related issues including investigation, root cause analysis, corrective action and customer feedback. Create top level part numbers and develop BOM’s. Manage CCO, sample, CoC and deviation processes for the supply base. Fulfil the role of the Person Responsible for Regulatory Compliance (PRRC) in the area of compliance Support preparation for regulatory and notified body external audits and provide backroom and frontroom support. Interested applicants should have: Working experience of a certified Quality Management System. Working experience of managing external suppliers, preferably with external Quality Auditor training. Document control and engineering change management experience. Knowledge of handling customer complaints. Knowledge of regulatory processes for EU and FDA product clearance. Some flexibility to travel to Asia / Europe to manage sub-suppliers (circa 10% - 15% of time is travel. You should have a third level degree and ideally a post-graduate qualification in Quality Assurance (an advantage, not essential. You should have a significant amount of experience in medical devices or other similarly regulated industries, with a certified quality management system. A knowledge of applicable quality systems for medical devices. In-depth knowledge of maintaining a certified Quality Management System. Knowledge and application of Quality tools and methodologies including lean six sigma, TQM etc. Experience of EN/MDD, ISO13485 and FDA requirements. Strong attention to detail.
64 days ago