QC Technician II

at  Thermo Fisher Scientific

POSITION SUMMARY:

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Perform in process quality inspections during manufacturing to determine if the product meets approved requirements.
• Identify and address 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.
• Record in process quality inspections to determine acceptance of materials from manufacturing.
• Track the number of defects identified during the inspection.
• Partner with Quality Assurance to identify opportunities for continual improvement based upon data collected.
• Partner with manufacturing personnel for line opening and line closing activities.
• Document nonconformances in the quality system and participate as needed in the DR/CAPA system.
• Disposition nonconformances to address a line down situation or as needed by manufacturing personnel to maintain line activity.
• Assist management and site with revision of departmental processes to ensure continual improvement.
• Alternate work schedule will be required to support changes in the manufacturing schedule. Weekend work and second shift work will be required but minimized as much as possible.
• Perform other duties as assigned.

MINIMUM REQUIREMENTS/QUALIFICATIONS:

• High School graduate or equivalent with a minimum of 3-5 years relevant experience in Quality Assurance or Quality Control preferred.
• 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.

PHYSICAL REQUIREMENTS:

• Normal laboratory/manufacturing environment.

Please refer the Job description for details