Ref. no.: MK/37560/IJP
Tags: Quality Engineer R&D Engineer R&D Quality Engineer Quality R&D Engineer
Location(s): Clare
Salary range (€): Negotiable
Additional benefits:
Minimum experience required: 2 - 3 Years
Employment type: Permanent Full-time
Minimum qualification: Third Level Degree
Contact person: Michelle Kilcar
Contact e-mail: michelle@ccprecruit.ie
Job description: R&D Quality Engineer RESPONSIBILITIES: Include but are not limited to the following: · Responsible for the support of the Design Control Process. · Ensure compliant closure of DHF's. · Support Project Managers in all aspects of Design Control · Support of Systems integration and Packaging Development from the QA perspective. · Review requests put on R&D from other technical areas under regulatory aspects. · Conduct Internal Audits to ensure compliance of Technical Department (R&D technical areas, CSU, Packaging Development and Systems Engineering) with ISO13485 and FDA quality requirements (e.g. calibration, training, document control etc). · Training for R&D technical staff on QSR/IVD requirements · Training for all relevant staff on Design Control procedures · Aid in updating all Design Control and R&D procedures / systems, as well as above mentioned departments, to ensure compliance with regulation ( FDA/ISO and IVDD) · Function as independent reviewer for projects at each gate for Design Control process. · Duties as prescribed by the OLMEI RA & Technical Area Quality Manager. EDUCATION: 3rd level qualification in Science, Engineering or Quality Assurance. EXPERIENCE Minimum of 2 years experience in quality function in a highly regulated (FDA desirable) healthcare or related environment. KNOWLEDGE & SKILLS: GMP/ Quality Standards - FDA - particularly - Design Control requirements, ISO9001, ISO13485, IVDD PC based applications-word, excel, etc Problem-solving techniques. Excellent interpersonal / communication skills Strong team member with the ability to identify and drive quality improvements Excellent Planning and organisational skills