Role: Snr Quality Systems Specialist
Location: Galway- Hybrid
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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