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 preferred and 1-year experience as an inspector.
- Ability to read blueprints and customer/internal specifications.
- Detailed knowledge of using precision measuring instruments. The instruments should include 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.