Senior QA​/QC Engineer | Start Up Biotech MNC RRKC

The Opportunity

Exciting opportunity for a highly skilled Senior Quality Engineer to join a Biotech MNC. As a Senior Quality Engineer, you will play a pivotal role in ensuring the company's products and processes meet stringent ISO 13485 standards and regulatory requirements.

• Develop, implement, and maintain quality control systems and procedures to ensure consistent product quality

• Conduct risk assessments, audits, and investigations to identify and resolve quality issues

• Collaborate with cross-functional teams to implement corrective and preventive actions

• Review and approve various quality-related documentation, including test protocols, validation reports, and standard operating procedures

• Provide technical guidance and training to production staff on quality control best practices

• Ensure compliance with applicable regulations, industry standards, and the company's quality management system

• Continually identify opportunities for process improvements and quality enhancements

• Bachelor's degree in Engineering, Quality Assurance, or a related field

• Minimum 5 years of experience as a Quality Engineer in the Biotech or Pharmaceutical industry

• Proven track record of developing and implementing quality control systems and procedures

• Strong understanding of ISO 13485 and other relevant quality standards and regulations

• Excellent problem-solving, analytical, and decision-making skills

• Effective communication and interpersonal skills, with the ability to interact with cross-functional teams

• Adaptable and proactive approach to continuous improvement

Chan Ku Ci: R
EA License No: 16C8261