Manager of Quality Compliance
2 weeks ago
Position Overview: The Quality Assurance Systems Director plays a crucial role in guaranteeing environmental and quality adherence by performing thorough research, evaluating data, overseeing the quality assurance initiatives, offering technical assistance, leading the Quality team, and fostering ongoing enhancement within the organization's quality frameworks and protocols.
Key Responsibilities:
- Plan, organize, and oversee the quality assurance initiatives to ensure that products align with established benchmarks.
- Implement and advocate for quality systems, standards, inspection protocols, and testing methodologies.
- Develop, execute, and assess quality reporting metrics while managing quality system challenges.
- Provide technical assistance and guidance for product manufacturing, including documentation, process flow diagrams, and raw material specifications.
- Ensure adherence to relevant regulations, including FDA and ISO standards.
- Analyze data to identify root causes of issues and execute corrective actions.
- Effectively manage multiple tasks with strong time management capabilities.
- Promote the Quality System as part of the organization's commitment to continuous improvement and compliance with policies and procedures.
- Serve as the primary Management Representative for ISO and the company’s Quality System.
- Engage in design development projects to advocate for Quality Systems.
- Design, document, and implement strategies for process control, enhancement, testing, and inspection.
- Report on quality system challenges, trends, and losses to management.
- Provide direction and support for the internal development and maintenance of the Quality System.
- Collaborate with the quality team on quality system issues.
- Recruit, train, and manage the Quality team, including overseeing promotions, demotions, transfers, and terminations.
- Address product deficiencies, monitor corrective actions, and ensure timely and accurate communication with customers.
- Assist or lead internal and external audits and deliver quality assurance training.
- Determine product disposition and assess retained, returned, and released products.
- Review and verify the accuracy of final release documents and customer complaints.
- Ensure product quality through daily control sheets and Quality shipping logs.
- Guide laboratory personnel on quality and product/processes and support technical development initiatives.
- Manage and maintain quality documents and ensure accurate inventory related to product release.
- Perform any other related duties as assigned.
- Exhibit exemplary attendance and punctuality.
Education & Experience Requirements:
A bachelor's degree or higher in a scientific discipline or a related field is mandatory. Experience with quality principles and the interpretation and application of industry regulations (e.g., ISO 9001) is essential.
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