Quality Manager
5 days ago
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- Develop and implement a robust Quality Management System (QMS) aligned with customer and regulatory expectations.
- Lead and mentor the quality team, promoting a culture of accountability and continuous improvement.
- Set and communicate clear quality goals and KPIs across relevant departments.
- Collaborate closely with Production and Quality Control to support all stages of quality assurance (IQC, In-Process, Final QC).
- Manage CAPA and Non-Conforming Product processes.
- Support internal, supplier, and regulatory audits.
- Lead and document complaint investigations and ensure timely issue resolution.
- Support R&D activities, including Design Assurance, Design Verification/Validation, FMEAs, and process validations.
- Conduct audits to ensure adherence to quality standards and recommend areas for improvement.
- Drive efficiencies within quality control processes.
- Apply structured problem-solving tools such as 8D, 7-step methods, 5 Whys, and risk assessments.
- Stay current with regulatory standards and ensure ongoing compliance (ISO, BRC, etc.).
- Act as a liaison with customers and regulatory bodies during quality-related interactions.
- Ensure ethical standards and code of conduct are upheld in all quality matters.
- Support supplier appraisal and approval processes.
- Monitor supplier performance and collaborate to resolve quality issues.
- Implement corrective actions and continuous improvement plans with suppliers.
- Maintain accurate quality records, metrics, and documentation.
- Generate and present regular quality reports and trends to senior management.
- Develop training programs to enhance staff understanding of quality standards and procedures.
- Ensure company-wide awareness and adherence to quality policies.
- Third-level qualification in Science, Engineering, or a related technical discipline.
- Strong data-driven decision-making capabilities with knowledge of SPC, Cpk, and quality tools.
- Additional qualifications in Quality, Validation, Statistics, or Risk would be a distinct advantage.
- Experience in validation processes, including Design and Process Validation.
- Proficiency in statistical analysis tools (e.g., Minitab).
- Solid knowledge of GMP, PM/TPM, and regulatory compliance standards.
- Strong written and verbal English communication skills.
- High attention to detail and excellent organizational skills.
- Proficiency in Microsoft Office applications.
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