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.