Senior Quality Systems Specialist

Cpl Group; Galway; Remote; EUR 60,000 - 90,000; Full time

Job summary

CPL is seeking a Senior Quality Systems Specialist for a remote, Ireland-based 12-month contract within a multinational medical technology environment. You will report to the Quality function and drive quality systems, regulatory compliance, and quality agreements across the business.

The role demands independent working style, strong stakeholder engagement, and a track record of process improvement and audit readiness in regulated settings.

Qualifications

• Bachelor’s degree in science, engineering or life sciences.
• Minimum 4 years' experience in Quality Systems or regulatory affairs.
• Strong understanding of quality management systems and regulatory requirements.
• Experience leading or supporting Quality Agreement activities.
• Ability to work independently with minimal supervision.

Responsibilities

• Oversee development, maintenance, and improvement of quality systems, processes, and procedures.
• Ensure compliance with internal quality standards, regulatory requirements, and industry guidelines.
• Provide expert guidance on quality system requirements and regulatory expectations.
• Lead Quality Agreement negotiations with suppliers, partners, and external stakeholders.
• Support cross-functional teams by conducting process reviews and providing quality oversight.
• Drive continuous improvement initiatives and recommend enhancements to existing systems and processes.
• Partner with stakeholders across the business to ensure consistent quality practices and compliance standards.
• Support audit readiness and regulatory inspection activities.
• Build strong relationships with internal and external partners to successfully deliver quality objectives.

Skills

Quality systems

Regulatory compliance

Stakeholder management

Process improvement

Project management

Education

Bachelor's degree in science or engineering

Job description

Role: Snr Quality Systems Specialist

Location: Remote - (Ireland Based)

Working Hours: 40 hours per week

Contract Type: 12-month contract + extensions

LTD or PAYE

About the Company

Here at CPL, we are supporting a leading multinational medical technology organisation who are currently seeking to hire an experienced Snr Quality Systems Specialist for an initial 12-month contract. This is an excellent opportunity to work on complex quality and compliance related initiatives within a global organization.

The Opportunity

Reporting into the Quality function, the successful candidate will provide expertise in quality systems, regulatory compliance, and quality agreements. This role will suit a quality professional who is comfortable working independently, influencing stakeholders, and driving quality excellence across a highly regulated environment.

Key Responsibilities:

• Oversee the development, maintenance, and continuous improvement of quality systems, processes, and procedures.
• Ensure compliance with internal quality standards, regulatory requirements, and industry guidelines.
• Provide expert guidance on quality system requirements and regulatory expectations.
• Lead Quality Agreement negotiations with suppliers, partners, and external stakeholders.
• Support cross-functional teams by conducting process reviews and providing quality oversight.
• Drive continuous improvement initiatives and recommend enhancements to existing systems and processes.
• Partner with stakeholders across the business to ensure consistent quality practices and compliance standards.
• Support audit readiness and regulatory inspection activities.
• Build strong relationships with internal and external partners to successfully deliver quality objectives.

Experience Required:

• Bachelor’s degree in science, Engineering, Quality, Life Sciences, or a related discipline.
• Minimum 4 years' experience within Quality Systems, Quality Assurance, Regulatory Affairs, or a related regulated environment.
• Strong understanding of quality management systems and regulatory compliance requirements.
• Experience leading or supporting Quality Agreement activities.
• Ability to work independently with minimal supervision.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong communication and stakeholder management experience.
• Proven track record in process improvement and quality system enhancement.
• Previous project management experience would be advantageous.

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