Position Overview
The Quality Manager will report directly to the Operations Director and will be instrumental in overseeing and enhancing the company's quality management system and quality assurance protocols. This role is pivotal in ensuring that all products and processes meet stringent industry standards including food, wastewater utilities and pharmaceutical industry standards, particularly focusing on product inspection and verification along with validation processes, regulatory inspections, customer audits, and independent regulatory audits. A robust approach to Corrective and Preventive Action (CAPA) management and fostering a culture of continuous improvement is a key aspect of the role.
Key Responsibilities
1. Quality Assurance and Compliance
* 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.
* Ensure all products comply to the highest industry standards, along with any specific customer requirements including compliance to CE and UL marking where appropriate.
* Support our engineering and sales teams in developing new by providing QA oversight and expertise for New Product and New Process Introductions.
2. CAPA Management
* Lead the CAPA program by identifying root causes of non-conformances, implementing corrective actions, and verifying their effectiveness.
* Monitor and analyse quality data to identify trends and areas for improvement, proactively addressing potential issues before they escalate.
* Collaborate with cross-functional teams to develop and implement preventive measures, reducing the likelihood of recurring quality issues.
3. Continuous Improvement
* 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, utilizing 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.
4. Supplier Quality Management
* 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.
5. Documentation and Reporting
* 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.
Qualifications and Experience Required
* 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 14001:2015 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.
* Proficiency in quality management software and Microsoft Office Suite with a particular expertise around excel would be advantageous.
Training and Development
The successful candidate will undergo a comprehensive onboarding program, including training on company-specific processes, quality management systems, and continuous improvement methodologies. Ongoing professional development opportunities will be provided to stay abreast of industry best practices and regulatory changes.
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