6479 - Senior Quality Manager

Agensi Pekerjaan Minde Group Sdn Bhd; Kulai; On-site; MYR 180,000 - 300,000; Full time

Job summary

Agensi Pekerjaan Minde Group Sdn Bhd invites applications for a Senior Quality Manager responsible for QA, compliance with medical device standards, and for developing quality systems.

You will lead the QA team, manage CAPAs, supplier quality, internal audits, and training, collaborating with engineering and procurement to ensure regulatory conformance and product excellence.

Qualifications

• Diploma or Bachelor's degree in Engineering, Science, or related field.
• Over 10 years of relevant management experience.
• Fluency in written and spoken English.
• Knowledge of ISO 13485 (current version).
• Strong data analysis and problem-solving capabilities.

Responsibilities

• Oversee Quality Assurance and implement quality systems to meet medical device regulatory requirements.
• Lead QA team; close CAPAs and nonconformities in the quality system.
• Develop and optimize inspection standards for materials, process control, and finished goods.
• Collaborate with engineering and procurement on supplier quality performance and assessments.
• Organize internal quality audits and provide training across the quality department.

Skills

Data analysis

Problem solving

English fluency

Leadership

Communication

Presentation

Global problem solving

Education

Engineering/Science degree

Job description

About the job 6479 - Senior Quality Manager

Job overview:

Responsible for overseeing Quality Assurance, contributing to strategic planning, and developing and implementing quality systems and control programs to ensure the delivery of high-quality products.

• Develop and establish the overall quality strategy, policy, and objectives for the organization.
• Implement, maintain, and continuously improve the quality management system.
• Set quality standards, create associated documentation, and ensure proper control and implementation.
• Lead the QA team to ensure products meet medical device regulatory requirements, company policies, and customer specifications.
• Develop and optimize inspection standards for incoming materials, process control, and finished goods.
• Monitor product performance to ensure conformance to regulatory requirements and specifications.
• Drive quality improvements based on inspection findings.
• Approve relevant quality system documents and the closure of nonconformities in the quality system.
• Oversee the closure of Corrective and Preventive Actions (CAPA) related to product quality.
• Contribute to, develop, and implement ideas to improve organizational performance.
• Collaborate with engineering and procurement teams in supplier quality performance management and supplier assessments.
• Handle internal and external customer complaints, working with customers and quality control teams to resolve quality-related issues.
• Organize and conduct internal quality audits to ensure compliance.
• Provide training to the quality department and raise quality awareness throughout the organization.
• Develop and implement document control programs and coordinate with global customers.
• Design and implement vendor quality programs.
• Maintain and enhance quality systems within the organization.
• Ensure adherence to Health, Safety, and Environmental (HSE) procedures in areas of responsibility.
• Perform other tasks as assigned by management.

Job Requirements:

• Diploma or Bachelor's degree in Engineering, Science, or a related field.
• Over 10 years of relevant management experience.
• Strong expertise in production procedures and quality control.
• Demonstrated leadership skills and strong business acumen.
• Familiarity with electronic production processes.
• Strong data analysis and problem-solving capabilities.
• Fluency in both written and spoken English.
• Knowledge of ISO 13485 (current version).
• High level of responsibility and accountability.
• Strong personality with excellent communication skills
• Good presentation and summary skills.
• Systematic, global approach to problem-solving.