Quality Technician

BUSINESS TITLE

Quality Technician II

BUSINESS UNIT / FUNCTION

Quality

LOCATION

O’Fallon, MO

OBJECTIVES/
PURPOSE OF JOB

• Ensure compliance of received and internal components, assemblies, and products to design requirements through physical, visual, and specialized testing and inspection.
• Document results in accordance with all pertinent procedural requirements.
• Create, validate, and implement receiving inspection and test processes to ensure component/product compliance.

KEY ACTIVITIES/
RESPONSIBILITIES

• Precision detail in identifying defects and inconsistencies.
• Complete and maintain accurate inspection documentation and perform inventory transaction in inventory management system.
• Meet time standards for inspection cycle times.
• Perform accurate counts of products inspected.
• Initiation of Non-Conformances and capture detail in CATSWeb.
• Document results of inspections per company procedures.
• Perform other duties as assigned.
• Follow all safety requirements.

SUPERVISE DIRECT REPORTS

(yes or no)

No

SCOPE OF POSITION

• All work performed must be completed with the highest Quality standards.
• Quality Inspections of incoming materials and products.
• Quality Control responsibilities for assigned site.
• Must be able to work up to 10 hours a day.  Must be able to work overtime as needed, including Friday, Saturday, and Sunday.

KEY RELATIONSHIPS

• Effective collaboration with other coworkers to provide a productive/ positive work environment.
• Manufacturing
• Engineering
• Supplier Quality
• Site Quality Assurance
• Research and Development
• Work with Procurement and suppliers as necessary to communicate and help resolve receiving inspection issues (documentation issues, nonconformances, etc.). 

QUALIFICATIONS/
TRAINING

Required Education:

• High School Diploma or equivalent.                         

Preferred Education:

• Training/certificate in quality inspection related field.

Required Skills/Qualifications:

• Must be able to effectively use an eye piece.
• Able to basic hand tools, calipers, micrometers.
• Ability to understand product drawings, specifications and visual work instructions.
• Ability to read, write legibly, speak, and understand English as well as basic math.
• Ability to work with little or no direction after being assigned.
• Able to perform inspections, checks, tests and sampling procedures in their assigned area.
• Must be able to use a microscope.
• Able to use and understand basic comparator functions.
• Good understanding of inspection and test techniques.
• Good hand-eye coordination and manual dexterity for small parts assembly. 
• Thorough knowledge of quality control standards and testing methodologies.
• Ensure the products and processes meet established quality standards and specifications.
• Basic knowledge and understanding of FDA Regulations, ISO 13485 requirements, and Quality System Standards and processes.
• Able to inspect incoming materials, parts and components used in the manufacture of medical devices. 
• Knowledge of GMP's (Good Manufacturing Practices) Regulations.
• Microsoft Excel – PowerPoint – Word

Specialized Training:

• Basic statistical knowledge including trends, pareto and other basic charting techniques.
• Ability to clearly describe quality issues e.g. Non-Conforming products, etc.
• Ability to perform product evaluations.

Preferred Skills/Qualifications:

• Working knowledge with automated measurement equipment.
• Experience with inventory management systems, document control systems.

Required Experience:

• Minimum 3 years of relevant experience in manufacturing or quality control role.

Preferred Experience: 

• Quality experience in a Medical Device Manufacturing Environment.