Quality Engineer

Sigmar Recruitment; Athenry; On-site; EUR 55,000 - 75,000; Full time

Job summary

Sigmar Recruitment is recruiting a Quality Engineer for an established medical device manufacturer in Galway, Ireland. The role focuses on maintaining and improving the site’s Quality Management System (QMS) and driving quality initiatives across processes and suppliers.

You will lead investigations, CAPA activities, and validation efforts, ensuring compliance with ISO 13485, ISO 14971 and ISO 14001, while supporting product transfers and risk management. A Lead Auditor qualification is required.

Qualifications

• Degree or equivalent qualification in Science or Engineering.
• Minimum 3 years' experience as a Quality Engineer in a medical device or regulated manufacturing environment.
• Strong working knowledge of ISO 13485:2016, ISO 14971:2019 and ISO 14001.
• Lead Auditor qualification is required.
• Strong experience in quality investigations, problem-solving and CAPA processes.

Responsibilities

• Drive continuous improvement initiatives across the facility via Lean QM practices.
• Lead investigations, CAPA activities and corrective actions.
• Lead validation activities across manufacturing processes and software systems.
• Conduct internal audits and support external audits.
• Ensure compliance with quality management and regulatory requirements.
• Support supplier management and drive supplier quality improvements.
• Develop and enhance the Quality Management System per industry best practices.
• Provide Quality support for new product introductions and transfers.
• Support risk management activities and related quality processes.

Skills

Lead Auditor

CAPA

Problem solving

Regulatory compliance

Education

Science or Engineering degree

Job description

Quality Engineer

Location: Galway, Ireland

Job Type: Permanent

The Opportunity

We are partnering with an established medical device manufacturer to recruit a Quality Engineer for their European facility in Galway.

This is an excellent opportunity for an experienced Quality Engineer to join an established Quality team, playing a key role in maintaining and continuously improving the site's Quality Management System (QMS). The successful candidate will drive quality improvement initiatives, lead investigations and CAPA activities, support product transfers and ensure compliance with relevant industry standards and regulatory requirements.

Key Responsibilities

• Drive continuous improvement initiatives across the facility, implementing Lean practices within the Quality Management System and reducing operational waste.
• Lead and participate in problem-solving activities, including CAPA, non-conforming product investigations and corrective action teams.
• Lead validation activities across manufacturing processes and software systems.
• Conduct internal audits and support external regulatory and certification body audits.
• Ensure products and processes remain compliant with relevant quality management and regulatory requirements.
• Support supplier management activities, driving supplier quality improvements and ongoing performance.
• Develop and enhance the Quality Management System in line with industry best practices.
• Provide Quality support for new product introductions and product transfers.
• Support risk management activities and associated quality processes.

Requirements

• Degree or equivalent qualification in Science or Engineering.
• Minimum of 3 years' experience in a Quality Engineer role, ideally within a medical device or regulated manufacturing environment.
• Strong working knowledge of ISO 13485:2016, ISO 14971:2019 and ISO 14001.
• Lead Auditor qualification is required.
• Strong experience in quality investigations, problem-solving and corrective/preventive action processes.
• Excellent organisational, communication and analytical skills, with strong attention to detail.
• Experience with Lean methodologies or a Lean qualification would be an advantage.

What's on Offer?

• Opportunity to join an established medical device manufacturing environment.
• A varied Quality Engineering position with responsibility for continuous improvement and quality system development.
• Exposure to regulatory compliance, validation, supplier quality and product transfers.
• Opportunity to make a meaningful contribution to site-wide quality initiatives.

Interested?

If you're an experienced Quality Engineer looking for your next opportunity within the medical device industry, we'd love to hear from you.