Quality Systems Specialist

Quality Systems Specialist – Elevate Your Career in Clinical Diagnostics!

Are You Ready to Make an Impact?

Do you have a passion for quality and a drive to ensure excellence in manufacturing? Are you looking for a role where your expertise can directly contribute to improving patient healthcare? If so, we have the perfect opportunity for you!

Join a Leading Clinical Diagnostics Company in Ballina, Co. Tipperary as a Quality Systems Specialist

Why This Opportunity?

This is more than just a job – it’s a chance to build a meaningful career. Our client, a world-class Clinical Diagnostics company based in Ballina, Co. Tipperary, is on a mission to enhance patient healthcare by delivering products and services that guarantee accurate and reliable diagnostic results. They’re looking for talented individuals like you to join their dynamic team!

What’s In It For You?

• Hybrid Working: Enjoy the flexibility of working from home combined with collaborative in-office days.
• Career Growth: Our client invests in their people, offering continuous learning and advancement opportunities.
• Impact: Your work will directly contribute to improving lives by ensuring the highest quality in diagnostics.

Your Role as a Quality Systems Specialist:

As a Quality Systems Specialist, you will be at the forefront of ensuring that our client’s manufacturing processes meet the highest quality standards. Your role will be multi-faceted, involving collaboration, analysis, and innovation.

• Define and Maintain Quality Standards:
  • Develop and enforce rigorous quality standards for suppliers to ensure all incoming materials and components meet the required specifications.
  • Work closely with the production and R&D teams to align supplier standards with product development goals.
• Supplier Collaboration and Quality Improvement:
  • Build strong, collaborative relationships with suppliers, guiding them in implementing continuous quality improvements.
  • Conduct regular assessments and audits of supplier facilities, providing feedback and support to address any areas of concern.
  • Negotiate and manage supplier quality agreements, ensuring clear expectations and accountability.
• Audits and Compliance:
  • Lead and support external audits, including those conducted by regulatory bodies (e.g., HPRA) and customers, ensuring full compliance with industry standards.
  • Prepare for audits by maintaining up-to-date documentation, conducting internal audits, and implementing corrective actions where necessary.
• Problem Solving and Continuous Improvement:
  • Participate in cross-functional teams to address quality issues, using root cause analysis and other problem-solving techniques to develop effective solutions.
  • Lead initiatives for continuous improvement, identifying and implementing best practices across the supply chain and manufacturing processes.
• Data Analysis and Reporting:
  • Continuously monitor and analyze supplier performance data, identifying trends and areas for improvement.
  • Prepare detailed reports on supplier performance, quality metrics, and audit outcomes, presenting findings to senior management.
• Support for Non-Conformance and CAPA Activities:
  • Provide expert guidance in handling non-conformances, ensuring timely and effective resolution.
  • Manage CAPA (Corrective and Preventive Actions) processes, ensuring that all issues are documented, analyzed, and corrected in compliance with regulatory standards.
• Documentation and Change Management:
  • Oversee the documentation control process, ensuring that all quality-related documents are properly managed, updated, and stored.
  • Support change control activities, ensuring that any changes in processes or materials are fully evaluated and approved before implementation.

Who You Are:

• Experience: You have a solid background in quality management within a manufacturing setting, with specific experience in supplier quality management.
• Education: A Bachelor’s degree in Manufacturing, Engineering, Quality Assurance, or a related field is required.
• Skills:
  • Strong analytical skills with the ability to interpret complex data and make informed decisions.
  • Excellent communication and negotiation skills, with the ability to build strong relationships with suppliers and internal teams.
  • Experience with regulatory audits and a deep understanding of compliance requirements in the clinical diagnostics industry.
• Attributes:
  • Detail-oriented and organized, with a passion for maintaining the highest quality standards.
  • Proactive and innovative, always seeking new ways to improve processes and outcomes.
  • A team player who can work collaboratively across different departments and with external partners.

Perks & Benefits:

• Generous Holidays: 25 days of annual leave to recharge and unwind.
• Life Assurance: Peace of mind with life assurance coverage.
• Retail Discounts: Save on your favorite brands with discounts from local and national retailers.
• Support When You Need It: Free 24/7 Employee Assistance Programme.
• Recognition: Excellence is recognized with monetary awards and recognition schemes.
• Long-Term Opportunities: A clear path for career advancement within a leading company in the clinical diagnostics field.

Ready to Join Us?

If you’re excited about this opportunity and believe you have the skills and experience we’re looking for, we want to hear from you! Apply today and take the next step in your career with a leading clinical diagnostics company.

Apply Now – Your Future in Clinical Diagnostics Starts Here!

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