Quality Engineer (Value Stream)
Collins Mcnicholas Recruitment
Job Summary: The Quality Engineer will primarily be responsible for maintaining and improving where necessary all quality systems and monitoring production process for compliance to implemented process controls. Duties and Responsibilities: Ensure continued compliance with all Regulatory Standards. This includes: Areas for Improvement to senior management. Validations. Engineering Change Order (ECO. Request for Corrective Action (RCA. Material Review Request (MRR. Internal Audits. Failure Mode Effect Analysis (FMEA. Variation Permits (VP. ISO 13485. FDA QSR. ISO 14000 and ensuring continued compliance with DMR. Monitor production process for compliance to implemented process controls to ensure quality product is shipped to customer and provide: Trend analysis of data from the controls. Potential improvements for review with engineering based on the trends. Review and propose changes to sampling plans based on trend analysis and changes to the system. Support the RCA meetings to ensure that internal and customer concerns are handled and dealt with in an appropriate manner. Review and ensure that area of responsibility documents listed below are approved in an appropriate and timely manner. Project meeting attendance as required. Attend and participate in daily cell meetings. Preparation of information for KPI and Management Review meetings. Skills and Knowledge: Ability to communicate and work with people inside and outside the department. Knowledge of engineering theories and methods. Good technical report writing skills and rigorous attention to detail. Minimum education and experience requirements: Engineering or science degree preferably with Quality Engineering included. Minimum of 3 years experience in a regulated environment. For a confidential discussionandmore information on the role,please contactEloísa Ruizon 021 4911066or email firstname.lastname@example.org. For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs, our job searching tips & videos! This job originally appeared on RecruitIreland.com.
248 days ago