18545-Quality Engineer-Carlow Contractor

Purpose

The Quality Specialist will perform an integral role in the company. They will work within a small team that will be mainly responsible for compliance aspects within the Engineering CoE team. This will include but not be limited to the completion of investigations, generation, and management of change controls and supporting the IFM Compliance and EHS Engineer as required.

Responsibilities

• Support Engineering activities through documentation generation, equipment, and process investigations associated with GMP activities, and completion of quality notifications.
• Be a document system expert; this will include document review, approval, and document system workflow expedition. Format, write, deliver, and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOPs, SWI’s, training documents, and change controls.
• Raise CAPA’s and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g., FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.
• Required to comply with Company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
• Support and lead Internal Quality audits of Engineering Dept.
• Assist in the management and/or assignment of Engineering training if required
• Work collaboratively to drive a safe and compliant culture.
• May be required to perform other duties as assigned.
• Experience in Compliance systems such as IPI, SAP, etc a distinct advantage
• Knowledge of regulatory/code requirements for Irish, European, and International Codes, Standards, and Practices
• Report, standards, and policy writing skills are required.
• Proficiency in Microsoft Office and job-related computer applications is required.
• Lean Six Sigma Methodology experience desired.
• Experience working within an Engineering environment in a regulated industry is a distinct advantage.

Requirements

• Degree qualification or equivalent Min Level 7 (Science, Engineering, Technical).
• Excellent communication, presentation, and interpersonal skills, to interface effectively with levels of colleagues and with external customers in a team-orientated manner.
• Excellent training, facilitation, and assessment skills
• Demonstrable analytical and systematic problem-solving skills.
• Strong influencing skills