EXAMPLES OF ESSENTIAL FUNCTIONS:
The list of essential functions, as outlined herein, is intended to be representative of the tasks performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position.
- Conducts and documents first article, in-process, and finished product inspections to determine if products are in compliance with order specifications; notifies the Production department accordingly
- Tags and isolates non-conforming parts; notifies the Quality Control Manager and operator(s)
- Writes non-conformance reports ensuring compliance with applicable rules and regulations
- Performs process validation measurements to include gage R&R and capability studies; reviews raw material listed on travelers
- Records test data applying statistical quality control procedures
- Evaluates data to identify deviations from specifications
- Recommends modifications to existing quality and production specifications to achieve optimal quality within the limits of equipment capability
- Understands and works toward Quality objectives and cost containment; continually optimizes the inspection process by identifying Quality bottlenecks that hinder production
- Assists with writing work instructions as required
- May assist with the Material Review Board (MRB), QA Final Release, and processing Engineering Change Orders (ECO’s)
EXAMPLES OF ESSENTIAL FUNCTIONS:
The list of essential functions, as outlined herein, is intended to be representative of the tasks performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position.
- Conducts and documents first article, in-process, and finished product inspections to determine if products are in compliance with order specifications; notifies the Production department accordingly
- Tags and isolates non-conforming parts; notifies the Quality Control Manager and operator(s)
- Writes non-conformance reports ensuring compliance with applicable rules and regulations
- Performs process validation measurements to include gage R&R and capability studies; reviews raw material listed on travelers
- Records test data applying statistical quality control procedures
- Evaluates data to identify deviations from specifications
- Recommends modifications to existing quality and production specifications to achieve optimal quality within the limits of equipment capability
- Understands and works toward Quality objectives and cost containment; continually optimizes the inspection process by identifying Quality bottlenecks that hinder production
- Assists with writing work instructions as required
- May assist with the Material Review Board (MRB), QA Final Release, and processing Engineering Change Orders (ECO’s)
MINIMUM QUALIFICATIONS:
High school diploma or GED; technical certificate preferred; supplemented by one or more years’ experience in quality inspections in a mid to heavy manufacturing environment; or an equivalent combination of education, certification, training, and/or experience.
KNOWLEDGE, SKILLS, AND ABILITIES:
- Knowledge and understanding of ISO 13485 and FDA 21CFR820 as it pertains to the job
- General knowledge of CMM operation, measuring tools, including but not be limited to, calipers, micrometers, depth gages, indicators, and plug and tread Go/No Go gages; may be trained on the job
- Skilled in the use computer software including but not limited to Microsoft Outlook, Word, and Excel and Visual Enterprise Resource Planning (ERP) software
- Skilled in basic math including but not limited to adding, subtracting, multiplication, division, geometric construction, practical algebra and metrics for the purpose of calculating material specifications
- Skilled in setting priorities that move projects through efficiently to achieve customer and quality objectives
- Skilled in working independently and following through with assignments with minimal supervision
- Ability to read blueprints preferred
- Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work
- Ability to learn and adapt to changing technology
- Ability to clearly communicate and understand information in English, both orally and in writing