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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.
Key Responsibilities
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
What We're Looking For
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
If you are keen to explore this career opportunity, kindly send a copy of your resume to [Confidential Information] or simply click the button to APPLY NOW! We regret that only shortlisted applicants will be notified.
Chan Ku Ci: R22111446
EA License No: 16C8261
Job ID: 152323717