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Form of work
SalaryOverview:
As a Quality Systems Engineer, you will play a pivotal role in ensuring that our organization maintains and continuously improves its quality management systems (QMS). You will be responsible for developing, implementing, and maintaining robust quality processes and procedures to support the organization's objectives. Your expertise will be instrumental in identifying areas for improvement, implementing corrective actions, and driving a culture of quality excellence throughout the organization.
Key Responsibilities:
- Manage and improve the quality management systems (QMS) in accordance with applicable standards and regulations (e.g., ISO 9001, ISO 13485, FDA regulations).
- Lead the design and documentation of quality procedures, work instructions, and forms to ensure compliance and efficiency.
- Conduct internal audits to assess compliance with quality standards, identify areas for improvement, and implement corrective actions as necessary.
- Collaborate with cross-functional teams to establish and maintain quality metrics and key performance indicators (KPIs) to monitor process performance and drive continuous improvement.
- Provide training and support to employees on quality procedures, standards, and tools to ensure understanding and adherence.
- Lead and support external audits and regulatory inspections, ensuring readiness and compliance with applicable standards and regulations.
- Investigate and resolve quality issues, non-conformities, and customer complaints through root cause analysis and implementation of corrective and preventive actions (CAPAs).
- Participate in the design and implementation of new products and processes, ensuring that quality requirements are integrated from the outset.
- Stay current with industry trends, best practices, and regulatory requirements related to quality management systems.
- Drive a culture of quality and continuous improvement throughout the organization by promoting awareness, accountability, and a proactive approach to quality assurance.
