Deskripsi Pekerjaan
Join our dynamic team as a Quality Manager in the medical industry, where you will play a pivotal role in maintaining the highest standards of quality and regulatory compliance. Based in Klang/Port Klang, this is an exciting opportunity for a seasoned professional to lead and elevate ISO 13485 quality standards across the full product lifecycle.
In this leadership position, you will be responsible for developing, implementing, and maintaining our comprehensive quality management system, ensuring full compliance with international medical device regulations while driving continuous improvement initiatives that enhance product quality and operational efficiency.
You will collaborate closely with cross-functional teams including R&D, production, and regulatory affairs to identify process improvements, conduct risk assessments, and ensure that all medical devices meet stringent safety and performance standards. Your expertise will be crucial in preparing for and passing internal and external audits, including FDA, CE, and ISO certifications.
This role offers competitive compensation, professional development opportunities, and the chance to make a significant impact on patient safety and product excellence in a growing medical device company. If you are passionate about quality assurance and want to be part of an organization dedicated to improving healthcare outcomes, we invite you to apply.
Tanggung Jawab
- Lead and manage the quality department, providing strategic direction for ISO 13485 compliance and continuous improvement initiatives
- Develop, implement, and maintain the Quality Management System (QMS) in accordance with ISO 13485 and relevant regulatory requirements
- Coordinate and conduct internal and external audits, ensuring timely closure of audit findings and corrective actions
- Collaborate with R&D and production teams to ensure quality standards are integrated into product design and manufacturing processes
- Perform risk management activities including FMEA, root cause analysis, and CAPA investigations
- Monitor and analyze quality metrics, preparing reports for senior management and recommending process improvements
- Ensure proper documentation control, including SOPs, work instructions, and quality records
- Stay updated with regulatory changes and industry best practices to maintain compliance and competitive advantage
Kualifikasi
- Bachelor's degree in Engineering, Quality Management, or related scientific discipline; advanced degree preferred
- Minimum 5 years of experience in quality management within the medical device or pharmaceutical industry
- Certified Lead Auditor for ISO 13485 with proven audit experience
- In-depth knowledge of medical device regulations including FDA 21 CFR Part 820, EU MDR, and ISO 13485
- Strong understanding of risk management principles (ISO 14971) and statistical quality control methods
- Excellent leadership, communication, and problem-solving skills with the ability to influence cross-functional teams
- Proficiency in quality management software and Microsoft Office applications
- Demonstrated track record of driving continuous improvement and achieving quality objectives in manufacturing environments