Senior Quality Engineer

ICDS Recruitment

Galway

Senior Quality Engineer - Galway. Key Job Responsibilities: • Establishing inspection standards, plans, frequencies and test methods. • Preparing and approving procedures, routing set-up's and shop floor documentation. Generate and approve change requests. • Preparing/Reviewing Master Validation Plans, FMEA’s, and Control Plans. • Make appropriate decisions on a daily basis. • Addressing customer complaints and getting to source of the issue. • Process owner of NCR process - getting to source of the issue and implementing CAR. Ownership of driving this process for assigned projects. • Drive continuous improvement and innovation from a quality perspective. • Performing an active role in further development of the quality management system. This will involve: • Performing internal audits to ISO and FDA requirements. • Upgrading system elements as appropriate. • Work with suppliers and customers on the resolution of product quality issues and quality improvement programs. • Quality representative on relevant Design team(s. • Ensure Projects quality records (batch documentation, calibration, incoming quality inspection, finished goods quality inspection) relating to assigned production areas are compliant for assigned projects. • Determining inspection frequencies and sampling plans using significant testing and capability studies; Implementation of Statistical Process Control in areas where needed and appropriate, analysis of data obtained. • Host Customer meetings and be available for regulatory audits at site and follow through with any corrective actions. • Support customer complaint analysis and post market surveillance activities. Interested applicants should have: • Degree in Quality, Engineering or equivalent. • At least five years’ experience in Quality environment, preferably in Healthcare/Medical Device industry. • Ability to work under strict time constraints and meet deadlines in a timely manner. • Proven ability to work independently and under own initiative. • Strong interpersonal and influencing skills. • Ability to work as part of a team and meet targets/goals efficiently. • PC skills including standard office packages as well as ability to understand and learn customized computer software programs. • Strong knowledge of quality principles and the ability to utilize these methods in a manufacturing environment. This job originally appeared on RecruitIreland.com.

2697 days ago