Quality Engineer

Vital Healthcare; Connacht; On-site; EUR 55,000 - 80,000; Full time

Job summary

Vital Healthcare seeks a Quality Engineer for its Galway manufacturing site to provide quality support and oversee validations, monitoring and calibration activities in line with GMP and regulatory standards.

The role requires a science-based qualification and experience in a regulated manufacturing environment, with a focus on quality systems, risk management and audits. Travel to supplier sites may be required.

Qualifications

• Bachelor's degree or higher in science, quality or related discipline.
• Experience in regulated manufacturing environments (GMP/GDP) and quality systems.
• Familiarity with EU IVDR/MDR and ISO 13485 is advantageous.

Responsibilities

• Provide quality support to site departments and maintain Quality Management System.
• Ensure compliance to GMP, EU IVDR, and regulatory requirements.
• Support regulatory inspections, customer and internal audits.
• Develop and maintain SOPs, validation protocols, risk assessments, and technical files.
• Oversee equipment qualification, validation and calibration activities.
• Drive continuous improvements across site manufacturing and quality systems.

Skills

Quality management

Regulatory compliance

Project management

Auditing (advantage)

Cross-functional collaboration

Education

Science degree (third level)

Job description

• Fannin LIP Galway is currently seeking a Quality Engineer to join our team at the Galway manufacturing facility. The role provides quality support and oversees validations, monitoring, and calibration activities across the site ensuring compliance with regulatory requirements and company quality standards.

The Opportunity

• Fannin LIP Galway is currently seeking a Quality Engineer to join our team at the Galway manufacturing facility. The role provides quality support and oversees validations, monitoring, and calibration activities across the site ensuring compliance with regulatory requirements and company quality standards.

Principal Duties And Responsibilities

• Provide quality support to the various departments across the site to ensure effective maintenance and implementation of the Quality management Systems.
• Ensure compliance to GMP, EU IVDR, and applicable regulatory requirements.
• Support regulatory inspections, customer audits, and internal quality audits.
• Develop, maintain, and ensure implementation of in-house documents e.g. Standard Operating Procedures, Validation Protocols, Risk Assessments, technical files, etc.
• Support issues management (Complaints, and Vigilance activities)
• Oversee and manage equipment qualification, validation and calibration activities for the site to ensure compliance with GMP, quality and regulatory requirements.
• Oversee the operations of onsite monitoring systems
• Perform quality assurance activities to ensure that raw material and finished product meet established quality, safety and performance standards.
• Support in the management of site level quality risk management and associated documentation.
• Drive continuous improvements initiatives across site relating to manufacturing, maintenance and quality systems.
• Lead quality related projects as assigned by Site Quality manager ensuring that they are delivered on time and within budget .

Experience & Profile

• Relevant Third Level qualification in science, quality or a related discipline (microbiology or validation qualification is an advantage)
• Experience in a regulated manufacturing environment, EU IVDR, EU MDR, GMP/GDP, and quality management systems ((ISO 17025/ISO 9001/ISO 13485).
• Experience with medical device risk management in accordance with ISO 14971 is preferable
• Experience in supporting validation activities e.g. equipment and/or testing qualification (IQ/OQ/PQ), change management and non-conformance investigations.
• Demonstrated project Management experience
• Auditor certified is an advantage

Other Information

• Strong analytical, communication and problem-solving skills are required for the role.
• Ability to work collaboratively across quality, manufacturing operations, and supply chain teams.
• Ability to independently priorities workload and manage competing demands in a fast-paced environment.
• Flexibility to travel to support supplier audits as required.

Please note although the above is a description of the requirements of the role, as stated in your contract of employment, you may be required to carry out other reasonable duties as the Company may require from time to time.

Please note that all Vital Healthcare staff work within quality management systems and that all the above will apply to the product portfolio.

Vital Healthcare is an Equal Opportunities Employer.