Quality Engineer (QMS Implementation and ISO Certification Specialist)

Job Overview:

We are looking for an engineer with strong QMS expertise and project management skills to lead the planning and transformation of the company's quality system. You will be responsible for establishing processes compliant with ISO 9001 standards from scratch, coordinating cross-departmental collaboration, and ultimately leading the company to successfully pass external certification audits.

Core Responsibilities and Tasks

This position is divided into two phases:

• The system establishment phase
• The maintenance and optimization phase.

1. 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.

2. Process Promotion and Internal Audit

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.

3. Quality Engineering and Continuous Improvement

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.

Job Requirements and Qualifications

Education: Bachelor's degree or above in engineering, quality management or related fields.

Work experience: More than 5 years of experience in quality engineering, and at least one successful case of leading the complete implementation of ISO 9001 from scratch to certification.

Professional certifications:

• Required: ISO 9001 internal auditor or chief auditor certification.
• Bonus points: ASQ Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt .

Key skills:

• 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 Speaking is a Plus.