Quality Control Inspector

Description

This position is critical to the accurate evaluation of incoming materials, component, subassembly and finished product quality. Responsibilities include inspection, analysis of results, determining final disposition of some product and detecting nonconforming conditions. The Quality Assurance Tech I is also responsible for working within an established framework of compliance and developing and/or implementing improvements to product quality and the quality system.

Principal Accountabilities

• Inspect incoming and in-process materials, for compliance with established quality specifications.
• Work with production, receiving, and materials personnel to accurately complete required testing and documentation, determine correct disposition, and apply correct status labeling.
• Update material disposition status in SAP.
• Detect nonconforming conditions during inspection and accurately document each condition.
• Demonstrate a bias for action to determine scope of nonconforming conditions and segregate nonconforming products to prevent further use.
• Develop and recommend actions to address nonconforming conditions or processes.
• Audit Device History Records for compliance to instructions including deviations or protocols and analyzing inspection results vs. specifications.
• Ensure accuracy and completeness of documentation, use of correct sample plans, materials utilized are released and correctly accounted for, and equipment used meets designated specifications including calibration.
• Perform or assist in investigations related to nonconforming product or customer complaints as required.
• Conduct spot audits to monitor and detect level of compliance in work cells.
• Participate in manufacturing or facility validation efforts at minimally a contributor level.
• Develop and implement process improvements within own area and work effectively with teams to identify and develop process improvements.
• Participate in Kaizen or other Continuous Improvement efforts.
• Demonstrate an understanding of the production processes for each supported work cell or value stream and articulate risk of defects or non-conformance's.
• Maintain state of 5 S in work area.
• Must perform work in a safe manner adhering to gowning and PPE procedures as well as periodically serve on safety committee.
• Handle hazardous materials as appropriate.
• Additional responsibilities as assigned by QA management.

Job Dimensions

• Schedule may need to flex based on business needs that may require non-traditional work weeks such as 4/10 hour days.
• Overtime duties may be outside of direct area of responsibility.

Qualifications

• Associates degree in quality, life sciences, or engineering related field. (May be equivalent to 2 years' experience)
• Proven ability to correctly interpret drawings and geometric dimensions and tolerances.
• Able to use standard measuring equipment including calipers, Random-Access memory (RAM) optic, micrometers, pin gauges, gage blocks, etc.
• Previous experience participating in Kaizen/continuous improvement activities
• Demonstrated understanding in the use of calibrated equipment and ability to follow equipment maintenance repair procedures
• High School Diploma / GED