Quality Engineer

Sigmar Recruitment; Galway; On-site; EUR 50,000 - 65,000; Full time

Job summary

Sigmar Recruitment is seeking a Quality Engineer to join a growing, regulated manufacturing site in Galway. You will provide quality support across departments and help ensure GMP, IVDR and MDR compliance.

You will lead validation and calibration activities, develop QA documentation, and drive continuous improvement across manufacturing, maintenance and quality systems. Collaboration with Quality, Manufacturing and Supply Chain will be essential.

Qualifications

• Third-level qualification in Science, Quality or a related discipline.
• Experience in a regulated manufacturing environment.
• Knowledge of EU IVDR, EU MDR, GMP/GDP and Quality Management Systems.
• Experience with ISO 17025, ISO 9001 and/or ISO 13485.
• Experience with medical device risk management and ISO 14971 desirable.
• Experience with validation activities (IQ/OQ/PQ) and change management.
• Demonstrated project management experience.
• Auditor certification would be an advantage.

Responsibilities

• Provide quality support across departments and maintain the site's Quality Management System.
• Ensure GMP, EU IVDR and applicable regulatory requirements are met.
• Support regulatory inspections, customer audits and internal quality audits.
• Develop, maintain and implement quality documentation including SOPs, validation protocols, risk assessments and technical files.
• Oversee and manage equipment qualification, validation and calibration activities.
• Drive continuous improvement initiatives across manufacturing, maintenance and quality systems.
• Lead quality-related projects, ensuring they are delivered on time and within budget.
• Support supplier audits and travel as required.

Skills

Analytical skills

Communication

Quality knowledge

Project management

Organisational skills

Cross-functional teamwork

Independent work

Education

Science/Quality related degree

Microbiology or Validation advantageous

Job description

Quality Engineer

Location: Galway
Job Type: Permanent
Sector: Medical Device / Life Sciences / Manufacturing

The Opportunity

We are currently recruiting for a Quality Engineer to join a growing manufacturing operation in Galway.

This is an excellent opportunity for an experienced Quality professional to join a regulated manufacturing environment where you will provide quality support across the site and play a key role in validation, equipment qualification, calibration, monitoring systems, quality management systems and continuous improvement.

The successful candidate will work closely with Quality, Manufacturing, Maintenance and Supply Chain teams, while ensuring ongoing compliance with relevant GMP, IVDR, MDR and quality management system requirements.

Key Responsibilities

• Provide quality support across multiple departments, ensuring the effective implementation and maintenance of the site's Quality Management System.

• Ensure compliance with GMP, EU IVDR and applicable regulatory requirements.

• Support regulatory inspections, customer audits and internal quality audits.

• Develop, maintain and implement quality documentation including SOPs, validation protocols, risk assessments and technical files.

• Support issues management, including complaints and vigilance activities.

• Oversee and manage equipment qualification, validation and calibration activities.

• Oversee the operation and performance of onsite monitoring systems.

• Perform quality assurance activities to ensure raw materials and finished products meet established quality, safety and performance standards.

• Support site-level quality risk management and associated documentation.

• Drive continuous improvement initiatives across manufacturing, maintenance and quality systems.

• Lead quality-related projects, ensuring they are delivered on time and within budget.

• Support supplier audits and travel as required.

About You

The ideal candidate will have:

• A relevant third-level qualification in Science, Quality or a related discipline. A qualification in Microbiology or Validation would be advantageous.

• Experience working within a regulated manufacturing environment.

• Knowledge and experience of EU IVDR, EU MDR, GMP/GDP and Quality Management Systems.

• Experience with standards such as ISO 17025, ISO 9001 and/or ISO 13485.

• Experience with medical device risk management and ISO 14971 is desirable.

• Practical experience supporting validation activities, including IQ/OQ/PQ, equipment/testing qualification, change management and non-conformance investigations.

• Demonstrated project management experience.

• Auditor certification would be an advantage.

Key Skills

We're looking for someone with strong:

• Analytical and problem-solving skills

• Communication and interpersonal skills

• Quality and regulatory knowledge

• Project management capability

• Organisational and prioritisation skills

• Ability to work collaboratively across multiple functions

• Ability to work independently and manage competing priorities

What's on Offer?

This is an opportunity to join a highly regulated manufacturing environment in Galway and take ownership of a broad range of quality engineering and compliance activities.

If you're a Quality Engineer looking for your next opportunity within the medical device, pharmaceutical or life sciences sector, we'd be keen to hear from you.