Quality Assurance Coordinator II at Insulet Corporation

Shanghai, Shanghai, China -

Full Time

Start Date

Immediate

Expiry Date

31 Dec, 25

Salary

0.0

Posted On

02 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Mechanical Inspection, Functional Testing, Package Integrity Testing, Quality Audits, Data Input, Inspection Records, Communication Skills, Organizational Skills, Basic Shop Math, FDA Standards, ISO Standards, Test Methods Development, Device Investigations, Calibration Monitoring, Spreadsheet Skills, Database Skills

Industry

Medical Equipment Manufacturing

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® 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! Position Overview: This position will be integral in controlling the inspection of incoming materials to support Insulet’s development and manufacturing areas. Must be able to deal with changing priorities. Will inspect incoming and in process sub-assemblies to Insulet quality documentation. Responsibilities: • Perform functional testing of devices as it pertains to lot qualification • Perform package integrity testing of devices as procedurally required • Mechanical inspection of incoming components and materials. • Maintain and file inspection records and reports. • Data input into the Insulet computer system. • Assist Quality Engineers in development of test methods and device investigations • Conduct internal quality audits, as required. • Monitor calibration contractors while testing equipment at Insulet. • Knowledge of basic shop math is essential. • Experience with FDA and ISO inspections documentation & standards. • Performs other duties as required. Education and Experience: Minimum Requirements: • High School degree • Demonstrated experience as a mechanical inspector in the Medical Device Industry Preferred Skills and Competencies: • Effective verbal and written communication skills. • Ability to communicate at multiple levels of an organization. • PC skill, word processing, spreadsheet, database. • Ability to organize and judge priorities. • Ability to generate and maintain accurate records. Physical Requirements: • Ability to lift up to 10 pounds. #LI-JW1 Insulet Corporation is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. (Know Your Rights) Insulet employees are all focused on the same goal — to make a difference. Our relentless passion is to simplify life for people with diabetes. We excite and empower employees to bring their best selves to work through a culture that supports a healthy work and life balance. We set the bar high to meet customer needs, and our priority is to ensure our employees are equipped and supported to help us get there. We foster and celebrate curiosity, innovation, and learning. Our teams work collaboratively and are empowered to drive the best actions for our customers. Our innovation spirit and customer-centric focus position us as global pioneers — leading the way to improve health outcomes with revolutionary medical devices while breaking down barriers to access.

Responsibilities

The Quality Assurance Coordinator II will be responsible for inspecting incoming materials and sub-assemblies to ensure compliance with Insulet quality documentation. This role also involves performing functional testing, maintaining inspection records, and assisting Quality Engineers with test methods and device investigations.