Quality Assurance Coordinator II

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
• • Minimum of 2 years 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.