Pale Blue Dot Recruitment | The Experts in MedTech Recruitment
Our client, a leading packaging solutions provider based in Limerick, is seeking a Quality Manager to join their growing team. This is an exciting opportunity for a driven and experienced quality professional to take ownership of quality management activities, working closely with operations, production, quality control, and R&D teams. The successful candidate will be responsible for ensuring compliance with industry standards, supporting continuous improvement initiatives, and upholding a strong quality culture across the organization.
Responsibilities Include but Are Not Limited to the Following:
Quality Management / Leadership
1. Develop and implement a robust Quality Management System (QMS) aligned with customer and regulatory expectations.
2. Lead and mentor the quality team, promoting a culture of accountability and continuous improvement.
3. Set and communicate clear quality goals and KPIs across relevant departments.
4. Collaborate closely with Production and Quality Control to support all stages of quality assurance (IQC, In-Process, Final QC).
5. Manage CAPA and Non-Conforming Product processes.
6. Support internal, supplier, and regulatory audits.
7. Lead and document complaint investigations and ensure timely issue resolution.
8. Support R&D activities, including Design Assurance, Design Verification/Validation, FMEAs, and process validations.
Process Improvement
1. Conduct audits to ensure adherence to quality standards and recommend areas for improvement.
2. Drive efficiencies within quality control processes.
3. Apply structured problem-solving tools such as 8D, 7-step methods, 5 Whys, and risk assessments.
Regulatory Compliance
1. Stay current with regulatory standards and ensure ongoing compliance (ISO, BRC, etc.).
2. Act as a liaison with customers and regulatory bodies during quality-related interactions.
3. Ensure ethical standards and code of conduct are upheld in all quality matters.
Supplier Quality Management
1. Support supplier appraisal and approval processes.
2. Monitor supplier performance and collaborate to resolve quality issues.
3. Implement corrective actions and continuous improvement plans with suppliers.
Documentation & Reporting
1. Maintain accurate quality records, metrics, and documentation.
2. Generate and present regular quality reports and trends to senior management.
Training & Development
1. Develop training programs to enhance staff understanding of quality standards and procedures.
2. Ensure company-wide awareness and adherence to quality policies.
Job Requirements
1. Third-level qualification in Science, Engineering, or a related technical discipline.
2. Strong data-driven decision-making capabilities with knowledge of SPC, Cpk, and quality tools.
3. Additional qualifications in Quality, Validation, Statistics, or Risk would be a distinct advantage.
4. Experience in validation processes, including Design and Process Validation.
5. Proficiency in statistical analysis tools (e.g., Minitab).
6. Solid knowledge of GMP, PM/TPM, and regulatory compliance standards.
7. Strong written and verbal English communication skills.
8. High attention to detail and excellent organizational skills.
9. Proficiency in Microsoft Office applications.
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