Director, Quality Operations

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 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!

Job Title: Director, Quality Operations

Department: Quality Operations

Manager/Supervisor: VP, QS and Operations

Responsibilities:

• The Director of Quality Operations will manage site-level Quality System compliance, ensuring full compliance of the site Quality System with US FDA, ISO 13485, and other applicable country-specific regulatory requirements.
• Perform role of site Quality System Deputy Management Representative with responsibility for ensuring processes needed for the Quality Management System (QMS) are documented.
• Report to top management on the effectiveness of the QMS and any need for improvement.
• Ensure promotion of awareness of applicable regulatory requirements and QMS requirements throughout the organization.

• Establishes, maintains and promotes a strategy for compliance with quality objectives.
• Ensures timely and accurate evaluations and investigations. Implements prompt actions as necessary to ensure product safety and efficacy based upon investigation results.
• Manages and ensures follow-up on activities related to Internal and External QMS Audits.
• Establishes, maintains and promotes a culture of compliance and a keen focus on quality and customer requirements throughout the site organization.
• Ensures an effective site Corrective and Preventive Action system.
• Establishes and maintains a robust employee training process.
• Supports and ensures establishment of a robust Environmental Monitoring program, if applicable for site.
• Supports and ensures sterilization controls and sterilization process validation program, if applicable for site.
• Ensures product is not released for distribution until all Device Master Record requirements have been met.
• Responsible for establishing and maintaining effective and efficient statistically-based Quality Control processes, i.e., incoming, in-process, and finished product inspection and release.
• Establish and maintain an effective and compliant site Document Control process.
• This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures.
• Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.

Requirements:

• Bachelor's degree (preferably science or engineering discipline) required.
• At least 15 or more years of experience in Medical Device Quality Operations with 10 or more years at the Quality Manager level.
• Fluent in both the English and Malay language.
• Strong leadership skill to build a strong team and promote teamwork.
• Good communication skill and work effectively across multiple levels and functions.
• Broad extensive knowledge of methods, processes, equipment, and techniques in manufacturing, development, and engineering.
• Significant knowledge and experience with designing and implementing QMS processes that meet the requirements of ISO 13485, 21 CFR 820, and MDR.
• Intermediate to advanced skill level of MS Word, Excel, Access, Auto Cad or equivalent.