The Manufacturing Quality Control Specialist is responsible for implementing and maintaining the effectiveness of the quality system by:
- Performing in process quality inspections during manufacturing to determine if the product meets approved requirements.
- Identifying and addressing in process quality defects in a timely manner to reduce the opportunity for repeated failures. This position will have the authority to stop the line in the event of an elevated defect rate under the guidance from a Quality Supervisor/Manager.
- Recording in process quality inspections to determine acceptance of materials from manufacturing.
- Tracking the number of defects identified during the inspection.
- Partnering with Quality Assurance to identify opportunities for continual improvement based upon data collected.
- Partnering with manufacturing personnel for line opening and line closing activities.
- Documenting nonconformances in the quality system and participate as needed in the DR/CAPA system.
- Assisting management and site with revision of departmental processes to ensure continual improvement.
- Perform other duties as assigned.
- Monday-Thursday, 3:30 p.m.- 2:00 a.m. with the possibility of overtime including weekends as required to support manufacturing schedule.
- High School graduate or equivalent with a minimum of 3-5 years relevant experience in Quality Assurance or Quality Control preferred.
- Previous manufacturing experience
- Experience and knowledge of ISO 13485 and 21 CFR 820 preferred.
- Familiar with inspection principles and concepts.
- Communicate effectively both verbally and written with personnel at all levels in a professional manner.
- Function in a team environment and receive direction and guidance from supervisor with minimal supervision.
- Detail oriented and has the ability to lead multiple activities assigned.
- Basic knowledge of computer applications required.
- Normal laboratory/manufacturing environment.
- Position may require frequent communication and walking to other areas in which designated PPE will be required.
- Position will require sitting and standing.
- Employee may occasionally lift and/or move up to 10 pounds.
This position is not approved for relocation benefits.
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