job description
Are you a detail-oriented professional looking to advance your career with a global leader in medical technology? Boston Scientific is seeking a dedicated Quality Technician to join our high-performing team in Penang. In this pivotal role, you will be the backbone of our quality assurance processes, ensuring that our products meet the highest safety and compliance standards in the industry.
As a Quality Technician, you will play an essential role in maintaining the integrity of our manufacturing line by managing Exception Reports and Non-Conformance Reports (NCRs). You will have the opportunity to work in a fast-paced environment where your keen eye for detail will directly impact patient lives and company excellence. If you are passionate about process improvement, root cause analysis, and medical device excellence, we want to hear from you.
Responsibility
- Manage and control the lifecycle of closed Exception Reports and Non-Conformance Reports (NCRs) to ensure full documentation compliance.
- Conduct regular, systematic line audits to ensure adherence to standard operating procedures (SOPs) and quality protocols.
- Facilitate and provide data for the Non-Conforming Report Board, ensuring timely resolution of production issues.
- Identify, document, and escalate quality deviations found during daily production monitoring.
- Collaborate with cross-functional manufacturing and engineering teams to resolve quality-related process gaps.
- Assist in the implementation of Corrective and Preventive Actions (CAPA) to improve overall manufacturing quality.
- Maintain accurate quality records and ensure all documentation meets ISO and regulatory compliance standards.
Qualifications
- Diploma or Degree in Engineering, Manufacturing, Quality Assurance, or a related field.
- Minimum 1-3 years of experience in a quality control or manufacturing environment, preferably within the medical device or pharmaceutical industry.
- Proficiency in using quality management systems (QMS) and documentation software.
- Strong understanding of ISO 13485 or similar regulatory quality standards.
- Excellent analytical skills with a proven ability to conduct root cause analysis.
- Strong communication skills, with the ability to clearly report findings to both technical and non-technical stakeholders.
- High level of attention to detail and ability to work effectively under pressure in a fast-paced environment.