Deskripsi Pekerjaan
Join Edwards Lifesciences as a Quality Systems Specialist and become a vital part of our commitment to excellence in medical device manufacturing. In this role, you will ensure our quality systems comply with established processes and regulatory requirements. You'll support changes to quality systems, manage Corrective and Preventive Actions (CAPA), and participate in Internal Quality Audits (IQA) to maintain the highest standards of product quality and safety. As a key member of our quality team, you'll work collaboratively with cross-functional departments to implement and maintain robust quality management systems that align with industry best practices and regulatory standards. Edwards Lifesciences offers a dynamic work environment where your expertise will directly impact patient outcomes through the quality of our innovative cardiovascular solutions.
Tanggung Jawab
- Ensure compliance of quality systems with established processes and regulatory requirements
- Support implementation and documentation of changes to quality systems
- Manage Corrective and Preventive Actions (CAPA) from initiation to closure
- Participate in Internal Quality Audits (IQA) and ensure effective implementation of corrective actions
- Maintain and improve quality documentation, including procedures, work instructions, and forms
- Collaborate with cross-functional teams to resolve quality issues and implement improvements
- Monitor and analyze quality metrics to identify trends and opportunities for improvement
- Stay current with regulatory requirements and industry best practices in quality management
Kualifikasi
- Bachelor's degree in Engineering, Life Sciences, or related field
- Minimum 3 years of experience in quality systems, preferably in medical device or regulated industry
- Strong knowledge of quality management systems and regulatory requirements (ISO 13485, FDA QSR)
- Experience with CAPA management, internal auditing, and quality documentation
- Excellent analytical skills with attention to detail and problem-solving abilities
- Strong communication and interpersonal skills with ability to collaborate effectively
- Proficiency in quality management software and documentation systems
- Certification in quality management (e.g., CQA, CQM) is preferred