Department: Quality Assurance
Reports To: Sr. Quality Engineer
The Quality Engineer will ensure that the quality-related requirements from our customers are communicated clearly and concisely to manufacturing, engineering, and the shop floor. The Quality Assurance Engineer will also work to reduce overall manufacturing quality costs to increase profitability and meet customer requirements while effectively teaching quality sciences to team members.
• Review customer quotes for overall quality requirements
• Perform dimensional and visual inspection of assigned products per established procedures
• Determine inspection methods/instructions and incorporate them into the manufacturing process and Quality Plans
• Develop and maintain FMEA, and Control Plans
• Outline/define measurements for CMM
• Design in-process gauging to be used by manufacturing and inspection groups
• Establish and maintain plant and Company-wide quality procedures
• Document all inspection/test results and any non-conformances found during inspections, testing or evaluations according to established procedures
• Performs disposition of material
• Maintain knowledge of all procedures, changes to specifications and new regulations related to areas of responsibility
• Support other QA/RA associates on defect awareness, inspection
• Adjust and prioritize work to meet deadlines while maintaining quality standards
• Consult with manufacturing engineers in resolving quality-related issues
• Establish and maintain a system that triggers effective corrective action
• Follow-up on all internal and external corrective action responses
• Conduct training on topics of customer and Company SOPs
• Project a positive and professional image of the company and of management to employees at all levels
• Supports process validations for new processes and re-validation of existing processes
• Other duties as deemed necessary by Management
KNOWLEDGE, SKILLS AND ABILITIES
• Manufacturing operations
• Measuring devices
• Quality systems
• FDA regulations
• GMP regulations
• ISO regulations
• Blueprint reading
• Problem solving and 8D
• Scheduling work to achieve goals
• Customer-focused environment
EDUCATION AND WORK EXPERIENCE
• Associate’s degree and one to two years experience in a similar quality role; or a combination of education and/or experience. Orthopedic manufacturing and ASQ certification preferred.
WORKING CONDITIONS/PHYSICAL ABILITIES
• Well lighted, heated/or air-conditioned indoor office/production setting with adequate ventilation.
• Light physical activity performing non-strenuous daily activities of a primarily administrative nature.
• Ability to maneuver throughout the facility/facilities as needed.
• Manual dexterity sufficient to reach/handle items and work with fingers.
• Ability to wear proper PPE
TRAVEL REQUIREMENTS: x YES NO some maybe required