Your new company Here at Hays we have an outstanding opportunity with our Wexford-based client, a leading family-owned company specialising in the design, engineering, and manufacture of bespoke products.
They cater to a diverse range of industries, such as pharma, food, wastewater, and the public sector.
The company operates under ISO 9001:2015 and ISO certifications, ensuring the highest standards of quality, safety and environmental management.
The person will work alongside the Operations Director and be instrumental in overseeing and enhancing the company's quality management system and quality assurance protocols.
Your new role Develop, implement, and maintain quality assurance policies and procedures aligned with our customer's needs, industry standards and regulatory requirements.
Oversee auditing, testing and validation activities, including equipment qualification, process validation, and metal finishing and cleaning validation, ensuring compliance with Good Manufacturing Practices (GMP).
Coordinate and manage internal and external audits, facilitating both customer and regulatory inspections, and ensuring timely resolution of any findings.
Lead the CAPA program by identifying root causes of non-conformances, implementing corrective actions, and verifying their effectiveness.
Promote a culture of continuous improvement by implementing Lean methodologies and Six Sigma principles to enhance process and product quality along with operational efficiency.
Lead quality improvement projects, utilising data-driven approaches to achieve measurable improvements in processes and products.
Provide training and mentorship to staff on quality principles, fostering an environment where quality is everyone's responsibility.
Establish and maintain robust supplier quality assurance processes, ensuring that all raw materials and components meet specified quality standards including full part level traceability where appropriate.
Conduct supplier audits and assessments, collaborating with suppliers to resolve quality issues and drive continuous improvement in the supply chain.
Ensure meticulous documentation of all quality assurance activities, maintaining records in compliance with regulatory requirements and company policies.
Prepare and present regular reports on quality metrics, CAPA status, and continuous improvement initiatives to senior management.
What you'll need to succeed Bachelor's degree in engineering, science, quality management, or a related field.
Minimum of 5 years' experience in a quality management role within the pharmaceutical equipment manufacturing or related or equivalent general manufacturing industry.
In-depth knowledge of GMP, ISO 9001:2015, and ISO standards and GDP.
Proven experience with Quality assurance management, CAPA management, and regulatory inspections.
Excellent project management skills.
Strong analytical skills with the ability to interpret complex data to identify problems and drive actionable corrective actions to resolve systemic problems.
Excellent communication and interpersonal skills, capable of leading cross-functional teams and interacting with regulatory bodies.
What you'll get in return Opportunity to be a part of a long-standing business that values long-term staff retention and continuous development Varied tasks and responsibilities, working cross-functionally with other departments to achieve success.
Competitive benefits and salary Modern work-place with ample parking What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
Hays Ireland is a trading division of Hays Specialist Recruitment (Ireland) Limited and acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers.
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