6465 - Senior Quality Engineer

Job Scope:

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

Requirement:

1. Possess at least a Degree in Electrical/Electronics or Mechanical Engineering.
2. At least 8 years of experience in Quality Assurance and/or Quality Management Systems, ideally within manufacturing or a quality-focused environment.
3. Solid background in Quality Control (QC) and Quality Assurance (QA), with specific experience managing quality processes in a manufacturing setup.
4. ISO standards such as ISO 2859 (sampling), ISO 9001 (quality management), ISO 13485 (medical device quality), ISO 14001 (environmental management), and ISO TS 16949 (automotive).
5. Current Good Manufacturing Practices (cGMP) for maintaining product safety and consistency.
6. Experience in Six Sigma methodologies is essential, with Green Belt or Black Belt certification preferred.
7. Proven experience implementing continuous improvement programs using Six Sigma or similar methodologies.