Job Description

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod\xc2\xae product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.





We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

Responsibilities:
Reporting to the Director, Quality Operations, the Manager, Quality System is responsible to implement and maintain the Insulet global Quality Management System (QMS) at Insulet Malaysia. The Manager, Quality System ensures the adoption, compliance, and documentation of the QMS at Malaysia in three areas; quality system, document control, and training.

Quality System: -

• Create and/or improve quality systems to ensure best practices are utilized. Perform assessments, write, and execute project plans, manage change.
• Review and approve Requirement Specifications, Quality Plans, Validation Protocols and Reports, as required
• Oversee the execution of electronic Quality System processes at Insulet Malaysia, such as CAPA, NCMR, and Quality Event
• Suggest methods for and improve quality system effectiveness with emphasis on preventive action.
• Perform quality system monitoring and analysis, including Document Control and Training
• Maintain the Quality Metrics Dashboard, and publish quality reports
• Assist in the development and execution of global and local QMS procedures

• Maintain QMS compliance to all applicable standards and country regulations
• Help define and lead in achievement of quality metrics
• Perform quality system monitoring and analysis
• Identify and steward the resolution of quality-related issues, especially those that impact the quality system processes
• In conjunction with applicable SMEs (Subject Matter Experts) at Insulet, create and/or improve quality system processes to ensure best practice, efficiency, and effectiveness
• Perform assessments, write and execute quality plans, manage change and continuous improvement Be an integral partner in the continued migration to electronic quality systems
• Maintain quality records and logs in compliance with global processes
• Represent Quality on various company projects and perform other duties as part of the Quality team as required

Document Control System: -

• Local process representative for global Document Control, specifically via the Arena LMS
• Maintain QMS documentation in Arena PLM per global procedures
• Participate in the development and roll-out of Document Control tools
• Control the flow of documents to support manufacturing, as required

Training Management: -

• Local process owner for the global Learning Management System.
• Work collaboratively with other functional groups to ensure timely completion and documentation of actions taken related to meeting Training requirements
• Establish ownership responsibilities for, and develop expertise in, Insulet\xe2\x80\x99s Learning Management System (LMS) to coordinate appropriate allocation of training and influence effective training
• Lead or participate in Training improvement projects
• Collaborate with Instructional Designer on creating effective training programs
• Maintain quality records and logs in compliance with MDSAP and ISO 13485 standards
• Performs other duties, as required

Requirements

• Bachelor\xe2\x80\x99s degree in scientific discipline or quality systems, preferred
• Minimum of 8 years\xe2\x80\x99 experience in quality systems within the medical device industry
• Working knowledge and experience with the application of medical device international standards and regulations, such as US FDA 21CFR820, EUMDR, ISO 13485 and MDSAP, and any applicable country-specific regulations
• Proficiency in root cause analysis and problem solving methodology
• Demonstrated effective verbal and written communication skills to multiple levels throughout the organization, both at Malaysia and at Corporate
• Ability to effectively manage people and judge priorities
• Experience leading or supporting MDSAP and./or ISO 13485 audits
• ISO 13485 Internal Auditor qualification and experience
• Experience with electronic systems such as QMS, Lifecycle Management, and Learning Management, preferred
• Ability to interface with a variety of people with different technical levels and educational backgrounds
• Detail-oriented and highly organized
• Ability to contribute to accurate and timely results in manufacturing while maintaining quality compliance and product safety
• Advanced user skills in Microsoft Word, Excel, and PowerPoint

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite