JOB REQUIREMENT / RESPONSIBILITIES

Role:

The Quality Manager is responsible for leading all Quality Assurance (QA) functions to ensure products meet customer requirements, regulatory standards, and company quality objectives. The role oversees the implementation and maintenance of Quality Management Systems (QMS), drives continuous improvement initiatives, and supports new product quality qualification activities.

Responsibilities:

• Lead and manage daily QA operations for consumer products and assembly processes.

• Implement and maintain ISO 9001, ISO 13485 QMS, and ISO 14001 EMS compliance.

• Lead the quality team in resolving quality issues and customer complaints.

• Monitor in-process and outgoing quality performance and drive improvement actions.

• Analyze internal and customer-reported defects with Engineering and Production teams.

• Ensure timely closure of customer complaints and effective CAPA implementation.

• Support supplier quality improvement activities and supplier audits.

• Support Engineering in process validation and quality planning activities.

• Review Control Plans, Inspection Plans, PFMEA, and risk management documentation.

• Manage first article inspections and sample evaluation activities.

• Work closely with customer R&D teams on new product requirements and process control setup.

• Provide training and development for Quality Engineers, Supervisors, and Inspectors.

• Prepare and manage departmental budget and quality objectives.

EDUCATION / ACADEMIC QUALIFICATION

• Bachelor’s Degree or Diploma in Engineering, Quality Management, or related field.

KEY REQUIRED EXPERIENCE, SKILLS AND ABILITY

• Strong knowledge of ISO 9001, ISO 13485 QMS, and ISO 14001 EMS.

• Certified Internal Auditor with audit experience in ISO 9001, cGMP, and ISO 14001.

• Familiar with SPC, GR&R, FMEA, DOE, MSA, and quality improvement tools.