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%).
