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Quality Engineer (QMS/Auditor)
Job Description
Qualifications:
Responsibilities:
- BS in an Engineering, Manufacturing, Quality Management
- 5+ years in Quality Engineering experience in a industrial manufacturing environment
- Demonstrated experience of at least one successful case of leading the complete implementation of ISO 9001 from scratch to certification.
- Required - ISO 9001 internal auditor or chief auditor certification
- ASQ Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt
- Proficient in ISO 9001:2015 standard requirements.
- Excellent cross-departmental communication skills can influence stakeholders at different levels.
- Data-driven decision-making ability, and proficiency in statistical software (such as Minitab) or SPC tools.
- Mandarin speakers prefer not required
Responsibilities:
- QMS Planning and ISO 9001 Certification
- Gap Analysis: Assess the differences between existing processes and the ISO 9001 standard.
- System design: Define the scope of QMS and design core processes (such as sales, production, procurement, after-sales service, etc.).
- Documentation management: writing, reviewing and maintaining quality manuals, second-level procedure books, third-level work instructions (SOPs) and forms and records.
- Audit Window: Serves as the sole technical contact point with external certification bodies and clients and leads the certification audit process.
- Company-wide training: Conduct ISO 9001 concept training for colleagues across departments to ensure that everyone understands their role and responsibilities in the QMS.
- Internal Audit: Develop an annual audit plan, train internal auditors, and conduct internal audits to ensure compliance.
- Management Review: Assist senior management in conducting management review meetings and reporting on quality performance and improvement needs
- Performance monitoring: Establish and track key quality indicators (KPIs), such as defect rate, customer complaint rate, and corrective and preventive action (CAPA) achievement rate.
- Problem Solving: Lead the team to use tools such as 8D, 5 Whys, or Fishbone to conduct root cause analysis and track the effectiveness of improvements.
- Risk management: Apply risk identification and risk assessment methods to prevent potential quality failures.