Quality Inspector

GENERAL DESCRIPTION

QC Inspector I is an entry level Quality Control Inspector with responsibilities that include inspecting, testing, sampling, and sorting products/goods being manufactured, inspections of incoming materials and components, in process subassemblies, and finished products.

ESSENTIAL FUNCTIONS

• Performs assigned routine tests on incoming materials and components, in process subassemblies, and finished products where results are compared with company and customer quality standards.
• Notifies supervisor when inspection data exceeds acceptable limits or when major incidents of poor quality are noted and follows procedures to reject, identify and segregate non-conforming product.
• Performs detailed inspections utilizing lad testing tools including but not limited to Snap Gauges, Calipers, Pin Gauges, Pressure Decay Tester, Calculator, Manometer, Microscope, Continuity Tester, Optical Comparator, Weigh Scale, Eye Loupe, Pull Tester, Burst Tester and other testing equipment when necessary to determine quality of product where limits are not clearly defined and determines trends.
• Reviews protocols, qualification, and validation procedures documented by the organization and follows those procedures. If a manufactured product does not meet quality specifications, the QC Inspector investigates and reports production line failures to the company.
• Establishes and accurately records results legibly and per Good Documentation Practices on applicable forms and includes these records in device history record.
• Maintain records relating to released lots of final product for traceability.

MINIMUM QUALIFICATIONS

• A High School Diploma required or equivalent experience and/or training
• Must possess strong math skills, good language, reading and writing skills (English)
• Regulated industry experience preferred. Exposure to Medical Devices & cGMP a plus.
• Able to read and interpret engineering drawings, specifications and inspection standards.
• Ability to set priorities & manage high volume workload; Must be self-motivated with flexibility to accommodate changing needs and requirements.
• Dependable and reliable with good attendance record.
• Ability to lift up to 40 lbs.
• Basic computer knowledge with data entry experience in various Microsoft applications.
• Working knowledge of quality standards, testing/sampling plans and testing equipment or their equivalent in work experience in similar job functions desired.
• Understand, dexterity and preciseness required to operate gauges and testing equipment within quality standards and without any unsafe acts.
• Read and interpret drawings with an understanding of dimensions.
• Team player with good communication and listening skills, manage business communication with other departments as needed.

SKILLS & KNOWLEDGE:

• Working knowledge of quality standards, testing/sampling plans and testing equipment or their equivalent in work experience in similar job functions desired.
• Understand, dexterity and preciseness required to operate gauges and testing equipment within quality standards and without any unsafe acts.
• Read and interpret drawings with an understanding of dimensions.
• Team player with good communication and listening skills, manage business communication with other departments as needed.

**** ** WORKING CONDITIONS **

• Work is primarily performed in a lab setting with frequent exposure to clean room and manufacturing areas, strong odors from solvents/bonding agents and little exposure to noise or heat.
• Physical effort is needed to move, lift, and carry product and materials.
• The nature of the work has frequent interruptions; contact with management and production staff
• Requires strong organizational & communication skills.
• May be required to work beyond normal working hours. Hours are subject to change without prior notification.