Quality Engineer
To ensure that products and manufacturing processes comply with all relevant quality, regulatory, and industry standards.
This role will support and enhance the Quality Management System (QMS), ensuring adherence to regulations such as FDA, ISO, and other applicable standards.
The Quality Engineer will collaborate with cross-functional teams to identify and resolve quality issues, conduct audits, and lead corrective and preventive actions (CAPAs).
Key Responsibilities
Maintain the Quality Management System (QMS) to ensure compliance with ISO 13485 and other relevant standards, continuously improving QMS documentation and processes.
Conduct product and process audits to ensure adherence to quality standards, regulatory requirements, and internal procedures, identifying areas for improvement.
Identify and resolve quality issues, collaborating with production, engineering, and other teams to implement corrective and preventive actions (CAPAs) to improve process efficiency.
Review and approve documentation such as device history records (DHRs), validation protocols, and change control records, ensuring accuracy and regulatory compliance.
Lead investigations for non-conformances, performing root cause analysis and implementing corrective actions to drive continuous improvement.
Conduct risk assessments for new and existing products, supporting risk management strategies in accordance with applicable standards.
Participate in supplier quality management, ensuring suppliers meet quality standards and conducting audits as needed.
Provide training and support to production, engineering, and other teams on quality standards, regulatory requirements, and best practices.
Monitor and report on key quality metrics, updating management on quality performance and areas for improvement.
Support product development projects, ensuring quality considerations are integrated throughout the product lifecycle.
Assist in preparation for regulatory inspections and audits, ensuring the company is always prepared for compliance evaluations.
Education and Experience:
Bachelor's degree in Engineering, Quality Management, or a related field.
3+ years of experience in a Quality Engineer role within a regulated industry (e.g., medical devices, pharmaceuticals, aerospace).
Experience working with Quality Management Systems (QMS) and standards such as ISO 13485 and FDA regulations.
Strong understanding of quality control principles, statistical analysis, and root cause analysis techniques.
Experience in conducting internal and supplier audits.
Ability to lead and implement corrective and preventive actions (CAPAs).
Knowledge of risk management principles and methodologies.
Excellent documentation and communication skills.
Ability to work effectively in a cross-functional team environment.
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