Deskripsi Pekerjaan
Join CICOR Panatec as a Senior Quality Assurance Engineer and play a pivotal role in maintaining excellence in medical device manufacturing. You'll drive quality initiatives across the product lifecycle, ensuring compliance with stringent ISO/GMP standards while supporting innovative injection molding processes. This position offers the opportunity to shape quality frameworks for New Product Introduction (NPI) projects and collaborate with cross-functional teams to deliver superior products to global customers. Your expertise in quality systems, process optimization, and regulatory compliance will directly impact our manufacturing excellence and customer satisfaction.
Tanggung Jawab
- Develop, implement, and maintain quality assurance procedures and tools aligned with ISO/GMP standards
- Lead quality audits and inspections for injection molding and manufacturing processes
- Manage quality aspects of New Product Introduction (NPI) projects from design transfer to production
- Investigate and resolve quality issues through root cause analysis and corrective actions
- Collaborate with engineering, production, and customer teams to ensure quality requirements are met
- Monitor quality metrics and drive continuous improvement initiatives
- Ensure compliance with regulatory requirements and customer-specific quality standards
Kualifikasi
- Bachelor's degree in Engineering, Quality Management, or related field
- Minimum 5 years of experience in quality assurance within medical devices or regulated manufacturing
- Expert knowledge of ISO 13485, GMP, and quality system standards
- Proven experience with injection molding processes and quality control methodologies
- Strong project management skills for NPI and process improvement initiatives
- Certified Quality Engineer (CQE) or Six Sigma certification preferred
- Excellent analytical, problem-solving, and communication skills