Quality Engineer

Overview

Glantech Staffing is partnering with a client in Longford to recruit a Quality Engineer responsible for ensuring all quality-related functions necessary for the smooth operation of the manufacturing site. Reporting directly to the Quality Manager, the role involves supporting the achievement of the company's quality goals in a manufacturing environment specialized in injection moulding or medical device production.

Responsibilities

• Develop and execute strategies to maintain and enhance the Quality Management System (QMS).
• Ensure and uphold compliance with ISO 13485 and ISO 14001 standards.
• Design and implement process control mechanisms to align with customer requirements.
• Conduct process validations and product qualifications to verify quality standards.
• Provide expert quality support for manufacturing processes and product disposition challenges.
• Utilize quality engineering analyses to formulate preventative strategies against defects and reduce risks.
• Manage the Non-Conformance Report (NCR) and Corrective and Preventative Action (CAPA) processes, ensuring prompt resolution of quality issues.
• Lead training related to quality procedures such as compliance, GMP, audit preparation, and Good Documentation Practices (GDP).
• Support the site during external audits and carry out internal quality audits.
• Track and analyze quality data trends to drive continuous improvement across operations.
• Assist with Environmental, Health, and Safety initiatives, including related training and compliance.
• Perform other duties as assigned by management.

Qualifications and Experience

• Third-level degree in Engineering, Polymer Science, or similar, or equivalent manufacturing experience.
• Proficient in statistical analysis tools such as Minitab; skilled in Statistical Process Control (SPC) and validations.
• Strong interpersonal, communication, influence, and facilitation abilities.
• Minimum of three years experience as a Quality Assurance Engineer within injection moulding or medical manufacturing sectors.