Director of Quality
3 weeks ago
Director of Quality Job Description
- Role: Executive position overseeing the Quality Management System (QMS), Quality Department, and Documentation.
- Reporting: Reports to the Group President, providing leadership for ensuring compliance with quality requirements across different departments and processes.
- Responsibilities: Focus on QMS development, performance metrics, compliance with standards (ISO9001, ISO13485, cGMP), and meeting customer requirements.
- Strategic Oversight: Evaluate QMS to ensure products and processes meet quality, integrity, functionality, and traceability standards.
- Collaboration: Work with management and senior staff across departments to establish quality metrics.
- Quality Standard Implementation: Develop and implement testing and evaluation processes, ensuring regulatory compliance and cross-departmental support.
- Stakeholder Communication: Facilitate communication with internal and external stakeholders in quality management.
- Continuous Improvement: Assess yield results and collaborate for overall Quality output enhancement.
- Documentation and Reporting: Review and own quality control documentation, and report quality control status to executive leadership and regulatory agencies when needed.
- Resource Management: Oversee staffing levels and resources to meet quality objectives.
- Decision Making: Ability to make critical decisions while adhering to company procedures.
Director of Quality Qualifications
- Education: Bachelor's degree in Engineering or Quality Management.
- Experience: 8+ years of related experience, preferably 5 years as a quality manager or similar role. Preferred training in Six Sigma, Lean Manufacturing, IPCA610, and IPCA620 standards.
- Computer Skills: Proficiency in Microsoft Office Suite, database management, and reporting.
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