Quality Engineering Lead

JOB TITLE: Quality Engineering Lead DEPARTMENT: Quality Department REPORTING TO: Head of Quality Individual Contributor or People Manager: People Manager OBJECTIVES OF POSITION: Manage a team of Quality Engineers responsible for operational quality activities. Manage Operational support to maintain effective support as required. Develop in house procedures, Work Instructions, best practice for problem solving and line investigations etc. As a senior member of the Quality department you will also be the mentor for Quality Engineers and Lead Quality Technicians ensuring information and Quality approach is best in class. Support the management of the Event Investigation forum and required best practice problem solving techniques including weekly Yield data gathering and monitoring on selected accounts as required. Support Weekly Customer reports as well as Quarterly Business Reports and data presentation when required. Training management of Quality Engineers ensuring all team members are focused on achieving company goals and targets. RESPONSIBILITIES: Manage Quality Engineering function including Quality Plans, FMEAs, control plans, SOP's and Event Investigations. Create, analyses, report and improve Product & Line Controls and ensure Quality Metrics are used to drive data decision making on a day to day basis. Review, approve and drive continuous improvement in event investigation forms and techniques. Driving required Corrective and Preventative action Improvements as output of Event Investigation process. Creation and Maintenance of departmental processes and procedures. Support External Agency Audits. Quality Tools & use of Best practice techniques and ideas. Quality Reporting/Metric gathering where required. Quality Improvement by account line and area. Other duties as required by the Head of Quality. Assure ongoing compliance with quality and industry regulatory requirements. Ensure compliance with Health & Safety Legislation and Regulations. MEASUREMENTS: Performance improvements in the above areas to current baseline. Improved customer satisfaction in delivered quality. EIF open / closed timeliness. Development, and training of Quality Engineering personnel. Completion of tasks / projects against set objectives in performance review. PERSONNEL SPECIFICATIONS Qualifications and Experience: 3rd Level Quality / Engineering or Technical Degree qualification Level 8 min. 2/3 Years experience in a high volume engineering environment with excellent understanding of Automation principles and associated Technical requirements. Ability to create a team environment conducive to problem solving. Working knowledge of current FDA Quality Systems Regulation, ISO 9001, ISO 13485, and the Medical Device Directive required. Proficient in use of Excel, Word, Power-point applications. Ability to read, analyse, and interpret quality metrics is preferred Ability to respond to common inquiries or complaints from internal customers and regulatory agencies is preferred. Ability to write standard operating procedures and training documents is preferred. Ability to effectively present information to customer and internal personnel at all level. Excellent communication and influencing skills are essential. Good understanding of Quality and Regulatory requirements related to the medical device industry. Good analysis and problem solving skills

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