Quality Inspector - 2nd Shift

Job Description

2nd Shift Hours: Monday - Friday 4:00pm - 12:00am

Job Duties and Tasks

• Performs and documents dimensional inspections on parts per order specifications and company quality control policies.
• Detect and tag Non-conforming parts and isolated in red bins.
• Evaluates data to identify deviation from specifications.
• Prioritizes daily workload based on production schedule and product priority.
• Receives requests from staff and reviews drawings for accuracy prior to release.
• Assist in the evaluation of work performed by secondary operators as needed.
• Records test data applying statistical quality control procedures as required.
• Completes functions required for MRB such as obtaining required signatures, following through with disposition of rejected materials and data entry as needed.
• Recommends modifications of existing quality and production specifications to achieve optimal quality.
• Understand and work toward Quality objectives and cost containment, responsible for continually optimizing inspection through-put and identifying quality bottlenecks hindering the production process.

Key Skills, Knowledge and Competencies:

• General knowledge and understanding of ISO 13485 and FDA 21 CFR 820 as it pertains to Inspection.
• High School or equivalent. At least 3 years' experience in Quality Control or Quality Assurance position at a Medical device manufacturer and 1-year experience as an inspector.
• Ability to read blueprints and customer/internal specifications.
• Detailed knowledge of using precision measuring instruments including, but not limited to, calipers, ID and OD micrometers, depth gages, indicators, and plug and tread Go/No Go gauges.
• Detail Oriented as shown by documented measurement accuracy.
• Proficient English communication skills - reading, writing, and speaking - as it relates to the job; Spanish a plus.
• Provide verbal instruction and training to quality personnel and operators on implementation of inspection methods and proper documentation.
• Skilled in basic math including but not limited to adding, subtracting, multiplication, division, and basic algebra for the purpose of calculating specifications.
• Skilled in adapting to a changing work environment, competing demands and ability to deal with frequent change, delays or unexpected events.
• Skilled in setting priorities that move projects through efficiently - achieving customer and quality objectives.
• Skilled in working independently, following through with assignments with minimal direction.
• Reasoning skills including but not limited to comparing, classifying, analyzing, and coordinating - minimizing duplication of effort.