QUALITY ASSURANCE TECHNICIAN

Overview:

Provide quality assurance support to the assigned program and/or area to ensure that the product is built in accordance with customer and division quality requirements while maintaining production flow

Specific Responsibilities:

Assist in the management of the company’s calibration and maintenance systems in accordance with regulatory requirements.
Assist with processing nonconformance reports, including the investigation for resolution.
Expedite nonconformance evaluation and disposition.
Conduct in-process and incoming inspection to approved procedures.
Assist in training of employees in new policies and procedures.
Determine acceptability of rework by inspection and/or test.
Perform packing line and manufacturing inspection.
Interpret manufacturing drawings, diagrams and specifications to approve or reject product or systems.
Apply appropriate approval or rejection labels to materials after data evaluation.
Review device history records and complete sterilization reports per approved procedures.
Supports the operations group while maintaining quality assurance policies and procedures
Performs other responsibilities associated with this position as may be appropriate.

Qualifications:

4+ years in medical device quality assurance or related field
A working knowledge of industry practices and current technology is required, as well as computer literacy and proficiency in utilizing appropriate software.
A working knowledge of FDA Quality System and ISO 13485 regulations.
Requires a motivated individual that can work with minimal supervision.