Quality Engineer (Med. Dev)

Sanderson Recruitment Ireland

Westmeath

SUMMARY DESCRIPTION. Key role of this position is to proactively support quality engineering activities with regards to the Quality Management System, product robustness changes & compliance related projects, ensuring technical correctness, & compliance with requirements of global regulations. This company is transferring a product from Ireland to the USA & they need someone to work on the QA s ide of this with the team. Under direct supervision of the QA Manager you will: - To perform this job successfully, an individual must be able to perform each essential duty satisfactorily: Working in conjunction with Engineering Departments, co-develop design verification & validation protocols for new products (or transfer) & for change on existing products, conduct design verification & validation studies, review & approve protocols, studies, & perform general oversight responsibilities for validation process, for both equipment & processes. Conduct detailed root cause analysis AN define corrective & preventive actions for NCR. Conduct Internal audit s & Supplier audit s against schedule. Develop Inspect ion plans for Incoming inspect ions, Inprocess & Final QA inspect ion for products manufactured. Detailed Review & approval of Risk Managements files. Review & Approval of Change Orders associated with components & manufacturing process, Lead quality problem investigations using proven quality tools & providing training as necessary to staff with respect to problem resolution, process or procedure changes. Ensure that requirements laid down in the quality manual & standard operating procedures are adhered too, & provide advice & guidance to other departments on quality related aspects. Provide Operational QA Support for products & process. QUALIFICATIONS/EXPERIENCE. Degree in Quality , Engineering or a Science discipline. 3-5 years' experience at quality engineering level within a regulated industry, preferably the Medical Device Industry. Demonstrable knowledge of FDA 21CFR820 &/or ISO 13485 regulations. Familiarity with use of ISO 14971:2007 an advantage. Ability to communicate effectively with management & fellow peers, both orally & in reports. PERSONAL COMPETENCIES. Good project planning & organizational abilities. Strong interpersonal & communications skills, including oral & written reports. Pro-active with proven ability to work under own initiative, & strong team player. Solid technical ability. Willingness to travel to other sites as part of duties. Please apply to the role and then we can discuss in detail. This job originally appeared on RecruitIreland.com.

2262 days ago