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: 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).
Top Skills
What We Do
Insulet Corporation, headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod® Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. Founded in 2000 (NASDAQ: PODD), Insulet operates with a customer-centric focus to supply high-quality products and expand the use of insulin pump therapy. Omnipod products are now available in 20+ countries around the globe.
HIRING SCAM ALERT
Recently, individuals impersonating Insulet Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists, please be aware that:
• Insulet will never interview a candidate over RingCentral, similar messaging apps or social media (i.e. Google Hangouts, WhatsApp, Facebook Messenger, etc.), or via text message.
• Insulet will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment.
• Insulet will never provide excess money to an applicant and ask the applicant to write a check for repayment.
If you have any doubt about a job offer or any other communication purporting to come from Insulet, please reach out to us directly at 978-600-7000.
If you receive any type of communication on behalf of Insulet that seems inappropriate or suspicious, please report this activity to: www.iC3.gov or www.stopfraud.gov
