Senior Quality Engineer

Job Summary:

The Senior Quality Engineer is pivotal in ensuring product, process, and service quality both internally and externally. They take a leadership role, overseeing corrective and preventive actions, root cause analysis, continuous improvement, quality training, and maintenance of the quality management system.

Essential Functions & Responsibilities:

• Quality Assurance Oversight:
  • Develop and implement quality assurance procedures and processes to meet customer quality standards.
  • Evaluate existing quality systems, recommending and implementing improvements.
  • Conduct regular audits to ensure adherence to quality standards and identify areas for enhancement.
• Quality Control Management:
  • Implement quality control checkpoints across the product lifecycle.
  • Collaborate with cross-functional teams to address quality concerns and implement corrective actions.
• Documentation and Reporting:
  • Maintain comprehensive documentation of quality processes, procedures, and test results.
  • Generate regular reports on quality metrics and communicate performance to stakeholders.
• Risk Assessment and Mitigation:
  • Identify and mitigate potential quality risks.
  • Conduct risk assessments on new products/processes, implementing preventive measures.
• Continuous Improvement Initiatives:
  • Lead internal and customer Corrective/Preventive Action (CAPA) systems.
  • Foster a culture of quality excellence through training and best practice promotion.
• ISO-9001 Compliance:
  • Implement and ensure compliance with the ISO-9001 standard.
  • Coordinate ISO-9001 audits, providing documentation and corrective actions.
• Supplier Quality Management:
  • Assess and monitor supplier quality performance, conducting audits as necessary.
  • Collaborate with procurement teams to address quality issues and enhance supply chain reliability.
• Customer Feedback and Satisfaction:
  • Monitor and address customer feedback and complaints related to product quality.
  • Facilitate RMA disposition meetings and review Failure Analysis reports.
• Leadership and Mentorship:
  • Provide guidance and mentorship to junior quality engineers and technicians.
  • Serve as a subject matter expert on quality processes and procedures.
• Project Management:
  • Lead quality-related projects, ensuring integration of quality considerations into project planning and execution.
  • Monitor project progress and address quality-related issues or risks.

Education and Experience:

• Bachelor of Science degree in engineering or related discipline required.
• Minimum 8 years related experience; supervisory experience preferred.
• Proficiency in team management and corrective action systems.
• Experience with an electronic Quality Management System (MasterControl preferred).
• ASQ certifications preferred but not required.

Competencies:

To perform the job successfully, an individual should demonstrate the following competencies:

• Ability to facilitate continuous improvement teams.
• Proficiency in tools such as CAPA, RCA, FMEA, SPC, etc.
• Strong organizational, analytical, and multitasking skills.
• Effective communication skills in English; knowledge of Japanese language helpful.
• Understanding of manufacturing environment and ISO 9001 quality policies.
• Ability to interpret mechanical drawings and familiarity with document control systems.
• Willingness to travel occasionally (less than 10%).