Quality Control Inspector-All Shifts

Qualifications

• a. High school diploma or GED required
• b. 0–3 years of relevant experience preferred; prior quality experience preferred, within GMP manufacturing environment is a plus
• c. Demonstrate all Basic Position Skills
• d. Familiarity with the fundamental concepts of Engineering drawings, inspection and documentation
• e. Demonstrate initiative and self-motivation to grow and succeed within the position
• f. Able to work semi-independently after initial training
• g. Display aptitude and willingness to learn and accept coaching
• h. Will receive hands-on training to support competency within the role
• i. Will receive opportunity and training to support growth within QC

• a. Flexibility – Able to adapt to shifting priorities and tasks
• b. Time Management – Able to balance multiple responsibilities and complete them efficiently
• c. Aptitude – Able to apply training effectively to assigned tasks
• d. Attention to Detail – Able to complete all documentation thoroughly and correctly
• e. Communication – Able to receive and give feedback and work well with others to achieve shared goals
• f. Mature work ethic – punctual with demonstrated good attendance record

Reports to: Quality Supervisor

Primary job responsibility: The QC Inspector Level 1 is an entry-level position within the Quality Control department. This position is focused on developing and applying foundational knowledge and the hands-on skills and competencies necessary for the inspection of extruded components utilized in Medical Devices. The Level 1 Inspector utilizes basic and foundational methods and gages to perform inspections of extruded product to determine conformance to defined specifications, adheres to GDP documentation requirements, and contributes to the daily productivity of the QC Team.

This position is performed with guidance and supervision with increasing independence with experience

• Perform Final Inspection for product Lot Release
• a. Prepare, follow and perform final inspections as defined on inspection paperwork for lot release
• b. Perform inspections using defined methods, gages and equipment
• c. Apply and follow ANSI and C = 0 Sampling Plans
• d. Document inspection results and complete all inspection paperwork as required
• e. Assess conformance to defined specifications and requirements
• f. Identify and document non-conformances to defined specifications and requirements
• g. Recognize, document and escalate quality concerns and issues
• h. Complete end-of-shift reporting
• Perform Start up and In-process inspection of manufacturing extrusion lines
• a. Prepare, follow and perform start-up and in-process inspections as defined on inspection paperwork of high-volume extrusion lines for production parts exhibiting recurring similar and consistent product geometries and materials and inspection methods
• b. Perform inspections using defined methods, gages and equipment
• c. Document inspection results and complete all inspection paperwork as required
• d. Assess conformance to defined specifications and requirements
• e. Identify and document non-conformances to defined specifications and requirements
• f. Communicate inspection results to the extrusion technician or operator
• g. Recognize, document and escalate quality concerns and issues
• h. Identify, document, and communicate at-risk product to appropriate personnel

• a. Utilize pin gages, ring gages, calipers, rulers, vision systems, and other applicable gages as specified and within scope of training
• b. Recognize and respond to basic visual and dimensional quality indicators and erroneous data
• c. Create efficiencies within the inspection process
• d. Identify and report equipment and gages outside of calibration dates and exhibiting damage, wear, or malfunctions

• e. Adhere to Good Documentation Practices (GDP) requirements
• f. Maintain accurate and complete records in all required documentation
• g. Follow defined processes and procedures appropriately and effectively
• h. Maintain product and lot traceability throughout the workflow and in all inspection documentation

• a. Follow all requirements and equipment…