Associate Engineer, Quality Systems (12 Months Contract)

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.

Job Title:                                         Associate Engineer, Quality Systems - Malaysia

Department:                                Quality Assurance

Insulet Corporation (NASDAQ: PODD) is an innovative medical device company dedicated to making the lives of people with diabetes easier. Through its OmniPod Insulin Management System, Insulet seeks to expand the use of insulin pump therapy among people with insulin-dependent diabetes.  Insulet's Delivery Systems business also partners with global pharmaceutical and biotechnology companies to tailor the OmniPod technology platform for the delivery of subcutaneous drugs across multiple therapeutic areas. 

Responsibilities:

• Maintain Quality System processes as system administrator, manage workflows, and perform related tasks (i.e. Learning Management System).
• Work collaboratively with other functional groups to ensure timely completion and documentation of employee training to meet Quality System requirements.
• Perform Quality System monitoring and analysis activities and publish management reports on specified timeframe.
• Lead or participate as the QA representative in Quality System improvement projects.
• Participate in Internal Audits, and support 3rd Party audit activities.
• Assist in the development of quality metrics dashboard & key performance indicators used for operational review meetings.
• Support local change admin by reviewing change orders on ARENA and provide relevant inputs i.e., change order acceptable or rejected, to change admin for their action.
• Maintain quality records, and logs (e.g. Internal/External Audit Records, critical Meeting Presentations, Rosters and Minutes, etc.), in compliance with FDA QSR and ISO 13485 standards.
• Performs other duties as required.

Minimum Requirements:

• Bachelor’s degree in science/engineering/computer systems/project management or quality management curriculum and/or equivalent combination of education and experience.
• Advanced knowledge of Microsoft Office programs (e.g. Word, Excel, PowerPoint and Power BI).

Preferred Skills and Competencies:

• 1-2 years’ work experience in a regulated industry, preferably medical devices.
• Knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and/or ISO 13485 quality system standards with experience in Certification inspections.
• Possess excellent communication (both verbal and written), leadership, and interpersonal skills.
• Critical thinking and problem-solving skills, with high attention to detail, especially in terms documentation review.
• Ability to multitask and be able to contribute positively as an individual and as a team player.

(On-Site): This position requires on-site working arrangements (requires on-site office/plant/lab work).