Quality Leader — Medical Devices & Regulatory Compliance

Masimo Corporation; Pasir Gudang; On-site; MYR 80,000 - 120,000; Full time

Job summary

A leading medical manufacturing company seeks a Quality Manager responsible for ensuring the highest quality standards and regulatory compliance. Candidates should possess a degree in engineering or a related field, with over 8 years of experience in quality management in the medical device industry. The role involves developing quality management systems, leading audits, and managing supplier quality. This position offers an opportunity for impactful leadership in a dynamic environment.

Qualifications

• 8+ years of experience in quality management within medical device or pharmaceutical manufacturing.
• In-depth knowledge of regulations like ISO 13485, FDA QSR.
• Strong experience with quality tools and methodologies to drive process improvement.

Responsibilities

• Develop, implement, and manage a robust quality management system compliant with regulations.
• Lead regulatory audits and inspections, collaborating with regulatory authorities.
• Oversee quality audits and establish procedures for product testing and validation.

Skills

Quality Management Systems

Regulatory Compliance

Quality Assurance

Supplier Quality Management

Risk Management

Quality Metrics

Training and Development

Cross-Functional Collaboration

Leadership

Education

Bachelor’s or master’s degree in engineering, Quality Management, Life Sciences

Tools

Six Sigma

Lean

Job description

A leading medical manufacturing company seeks a Quality Manager responsible for ensuring the highest quality standards and regulatory compliance. Candidates should possess a degree in engineering or a related field, with over 8 years of experience in quality management in the medical device industry. The role involves developing quality management systems, leading audits, and managing supplier quality. This position offers an opportunity for impactful leadership in a dynamic environment.