QE Technician

Insulet Corporation Billerica, MA
Position Summary

This position will be integral in investigating lot qualification test results to support Insulet's development and manufacturing areas. This position will primarily work within the QC Lot Qualification group as an investigative technician to complete timely root cause investigations and work with Manufacturing and Engineering to drive process improvements. Must be quickly adaptive to changing priorities. This position will also support lot qualification testing and other QE supporting assignments when needed.

Responsibilities

* Perform daily root cause investigation analysis of test failures and errors.

* Responsible for generating routine trend analysis reports and communicating trends to Engineering and Manufacturing groups.

* Collaborate with Manufacturing to consolidate and analyze pre and post sterile test data.

* Perform functional testing of devices and packaging testing as it pertains to lot qualification, when needed.

* Maintain and file inspection records and reports.

* Data input into the Insulet computer system.

* Assist Quality Engineering in development of test methods, resolution of nonconformances, and investigations.

* Support quality audits, as required.

* Monitor calibration contractors during calibration of investigation test equipment at Insulet.

* Perform other duties as required.

Education and Experience

* Bachelor's Degree in a scientific discipline such as engineering; or Associates Degree in a scientific discipline such as engineering with minimum 1 year of relevant experience.

* Prior experience working in the medical device or similar FDA-regulated industry is strongly preferred.

Skills/Competencies:

* Must be proficient with general computer skills and Microsoft applications, specifically Word and Excel. Experience with statistical software programs like MiniTab is preferred.

* Must be mathematically competent.

* Effective verbal communication and organizational skills.

* Effective technical writing capability.

* Must demonstrate great attention to detail and have ability to work efficiently.

* Ability to generate and maintain accurate records.

Physical Requirements:

* Ability to lift up to 10 pounds.