Quality Assurance Coordinator II

Responsibilities

• Perform mechanical inspection of incoming components and materials
• Conduct functional testing of devices for lot qualification
• Perform package integrity testing as procedurally required
• Maintain and file accurate inspection records and reports
• Input data into the company computer system
• Assist Quality Engineers with test method development and device investigations
• Conduct internal quality audits and monitor calibration contractors
• Manage changing priorities to support development and manufacturing areas

Requirements

• High School degree
• Minimum of 2 years of experience as a mechanical inspector in the Medical Device Industry
• Knowledge of FDA and ISO inspection documentation and standards
• Proficiency in basic shop math
• Ability to lift up to 10 pounds

Preferred Qualifications

• Effective verbal and written communication skills
• Ability to communicate effectively across multiple levels of an organization
• Proficiency in PC skills, including word processing, spreadsheets, and databases
• Strong organizational skills and the ability to judge priorities

About the Company

Insulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. Our flagship Omnipod Insulin Management System provides a unique, wearable, and tubeless alternative to traditional insulin delivery methods. We foster a culture of curiosity, innovation, and collaboration to improve health outcomes worldwide.