QUALITY ASSURANCE TECHNICIAN
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
- 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.
- 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.