QMS Lead & Internal Auditor — ISO 9001/17025 Expert

Advanced Energy; Penang; On-site; MYR 90,000 - 150,000; Full time

Job summary

Advanced Energy in Penang is seeking an experienced Quality Manufacturing System Specialist II to establish and harmonize site-wide QMS compliant with ISO 9001 and ISO/IEC 17025 standards, and manage corporate document control workflows, policies, and standard operating procedures (SOPs).

The ideal candidate will have strong background of administration of departmental policies and procedures in manufacturing and laboratories and hands on experience to mentor and organize with cross functional

Qualifications

• English communication skills in verbal and written.
• Familiar with ISO9001 & ISO17025 requirements, and internal auditor certification is preferred.
• Solving problem skills, able to coordinate people from different departments for quickly solving quality issues.
• Data analysis ability, able to find potential quality issues as early as possible.
• Skills of basic quality tools and quality improvement tools.
• Creative ability, technical skill and independent judgment ability.
• PC skills, can properly present quality issues and reports with Email, Excel, Word, PowerPoint, etc.
• Understanding of ESD compliance, calibration processes, and workmanship standards.

Responsibilities

• Maintain and improve the QMS: procedures, work instructions, forms, and document control; ensure controlled, current, and accessible documentation.
• Establish ISO17025 quality management system that ensures technical competence and reliable testing or calibration results.
• Provide QMS input during new product transfers and new line qualifications; ensure process readiness and validation evidence are in place.
• Plan, schedule, and perform internal audits according to the audit plan.
• Support external audits from customers, certification bodies, and regulatory agencies.
• Track and close audit findings and corrective actions.
• Maintain audit readiness across all departments.
• Support the other manufacturing sites for new system setup or cross audits
• Lead root cause analysis activities using tools such as 5 Whys, Fishbone, or Fault Tree Analysis.
• Manage the internal audit system, including initiation, investigation, action planning, implementation, and verification of effectiveness.
• Track CAPA trends and report on status and performance.
• Deliver QMS training to build quality awareness and understanding across teams.
• Support change control processes to ensure risks are assessed and changes are properly documented.
• Collaborate with Engineering, Production, Supply Chain, and other functions to ensure product and process quality.
• Provide QMS-related input during product development and process validation.
• Maintain confidentiality of all information related to the production processes and components, business and other technology including materials.
• Adhere to organizational requirements on quality management, health and safety, code of conduct, legal stipulations, environmental, 5S policies and general duty of care
• Other duties as assigned.

Skills

Quality management

Audit coordination

Data analysis

Problem solving

Communication skills

ISO knowledge

PC skills

Education

Bachelor's degree in Electrical/ Electronics/ Mechanical Engineering

Tools

Quality tools

Job description

Advanced Energy in Penang is seeking an experienced Quality Manufacturing System Specialist II to establish and harmonize site-wide QMS compliant with ISO 9001 and ISO/IEC 17025 standards, and manage corporate document control workflows, policies, and standard operating procedures (SOPs).

The ideal candidate will have strong background of administration of departmental policies and procedures in manufacturing and laboratories and hands on experience to mentor and organize with cross functional