Quality Assurance Coordinator I

Shift Hours: 8:00 AM - 4:30 PM. Overtime depends on forecast/demand.


FDA/ISO Documentation Experience: Required (since it s a key priority for the role).
Medical Device Industry Experience: 2+ years in inspection required. However, other industries are acceptable if the candidate has the relevant knowledge.


Position Overview:

This position will be integral in controlling the inspection of incoming materials to support Company s development and manufacturing areas. Must be able to deal with changing priorities. Will inspect incoming and in process sub-assemblies to Company quality documentation.

Job Description:

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 Company 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 Company.
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 to 10 pounds.