Quality Assurance Engineer — Drive Compliance & Improvement

Sterling Engineering Ltd - Ireland & Europe; Sligo; On-site; EUR 42,000 - 62,000; Full time

Job summary

Sterling Engineering Ltd - Ireland & Europe is seeking a Quality Engineer to ensure products meet approved specifications and regulatory requirements, while supporting cGMP environments and QMS activities.

You will lead inspections, CAPA investigations, audits, and risk management alongside cross-functional teams. The role emphasizes documentation, training, and continual improvement in a regulated manufacturing setting.

Qualifications

• Degree in Science, Engineering, Quality or related discipline
• Minimum 2 years in a regulated manufacturing quality system (medical devices preferred)
• Knowledge of ISO 9001/13485 and FDA 21 CFR Part 820 desirable
• Experience in CAPA, investigations, audits, validation and risk management advantageous
• Green Belt or statistical knowledge desirable
• Experience in injection moulding or tooling advantageous

Responsibilities

• Coordinate and maintain elements of the Quality Management System (QMS).
• Participate in internal, external, and supplier audits.
• Investigate nonconformances and customer complaints; support root cause analysis and CAPA implementation.
• Monitor CAPA progress, closure and effectiveness.
• Track quality metrics and prepare reports for management review.
• Provide quality and compliance training to personnel.
• Support validation activities, risk assessments and continual improvement initiatives.
• Review batch records and documentation; support release and disposition.
• Perform or support inspections and testing (incoming, in-process, final).
• Manage supplier quality issues and ensure compliance with specifications.
• Maintain accurate quality documentation and training records.
• Promote a strong quality culture and EHS compliance.

Skills

Analytical skills

Problem solving

Attention to detail

Documentation

Communication

Cross-functional collaboration

Education

Degree in Science/Engineering/Quality

Job description

Sterling Engineering Ltd - Ireland & Europe is seeking a Quality Engineer to ensure products meet approved specifications and regulatory requirements, while supporting cGMP environments and QMS activities.

You will lead inspections, CAPA investigations, audits, and risk management alongside cross-functional teams. The role emphasizes documentation, training, and continual improvement in a regulated manufacturing setting.