Sr. Quality System Analyst
On-siteIso, Hyōgo, Japan
Job Summary
Implement, maintain, and continuously improve the Integrated Management System (IMS), including Quality, Environmental, and Information Security Management Systems. Plan, conduct, report, and follow up on internal audits, managing the issuance, verification, and closure of corrective actions. Develop, review, and maintain Quality Procedures, Work Instruction Procedures, Standard Operating Procedures, and other IMS documentation while reviewing and approving document change requests. Monitor departmental Key Performance Indicators and drive corrective and preventive actions. Lead and support continual improvement initiatives to enhance IMS effectiveness. Collaborate with cross-functional teams to resolve quality, environmental, and compliance issues. Provide training and guidance to employees on IMS requirements and best practices. Support internal, customer, certification, regulatory, and third-party audits. Serve as the subject matter expert for IMS-related inquiries and identify, communicate, and escalate compliance risks to management. Plan and coordinate external audits by certification bodies, notified bodies, customers, and regulatory agencies.
Required Qualifications
- Bachelor's degree in Engineering, Quality Management, Environmental Science, or a related field
- Minimum of 5 years of relevant experience with a Bachelor's degree, or 3 years with a Master's degree, in Quality, Environmental, or other Management Systems within a manufacturing and/or high-tech environment
- Experience developing, implementing, and leading Quality and Environmental Management System audits in the semiconductor, electronics manufacturing, pharmaceutical, medical device, or related industries
- Strong working knowledge of international management system standards, including ISO 9001, ISO 13485, ISO 14001, ISO 27001, AS9100, and IATF 16949 (formerly ISO/TS 16949)
- Certified Internal Auditor certification for one or more ISO standards
- Demonstrated ability to influence and collaborate effectively with cross-functional teams, customers, suppliers, and all levels of management
- Excellent verbal, written, presentation, and interpersonal communication skills
- Strong organizational, analytical, and problem-solving skills with the ability to manage multiple priorities in a fast-paced environment
- Proficient in Microsoft Office applications, including Excel, Word, PowerPoint, and Outlook, with experience in data analysis and reporting
- Knowledge of risk management methodologies (e.g., FMEA, Fault Tree Analysis) and performance measurement using Key Performance Indicators (KPIs)
- Ability to work independently while managing multiple projects and meeting deadlines
Desired Qualifications
- Master's degree
- Certified Internal Auditor certification for one or more ISO standards
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