Senior Quality Management Specialist
2 weeks ago
Job Title: Senior Quality Management Specialist
About the Role:
- Develop and implement a comprehensive Quality Management System (QMS) that integrates across all functions of the organization.
- Conduct regular reviews, assessments, and internal audits to maintain compliance and identify areas for improvement in quality standards.
- Oversee quality assurance activities for incoming materials, in-process checks, and outgoing products to drive improvements in product quality.
- Implement quality control plans tailored to each product line, ensuring consistency in manufacturing output and adherence to quality standards.
- Work closely with suppliers to ensure compliance with quality standards, conducting audits, evaluating performance, and managing corrective actions.
- Coordinate the Material Return Board (MRB) and Return Material Authorization (RMA) processes to address any product defects or non-conformances, ensuring timely resolutions.
- Collaborate with cross-functional teams during the NPI phase to develop quality plans for new products, focusing on ensuring supplier and manufacturing readiness.
- Support the procurement team by aiding in supplier qualifications and periodic evaluations, particularly for suppliers involved in critical components.
- Analyze and maintain supplier quality metrics, track supplier performance, and manage return-to-vendor processes as necessary.
- Oversee supplier corrective and preventive actions, monitoring improvements through 8D reports and supplier performance ratings.
- Ensure adherence to quality and regulatory standards, such as ISO 9001, ISO 13485, ISO 14001, TS 16949, and cGMP.
- Lead compliance initiatives and ensure factory adherence to quality system standards, including specific product regulatory requirements.
- Supervise and develop quality inspection staff, providing coaching to Quality Inspectors, Technical Operators, and Document Controllers.
- Perform ad-hoc duties as assigned.
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