FLSA Status
• Salary Exempt
Reports To
• Manufacturing and Quality Engineering Manager, Quality Manager, or Quality Engineer III
Education/Experience
• BS in Engineering required
• 3 + years experience in quality engineering preferred
Essential Functions, Knowledge and Competencies
• 6 sigma, SPC preferred
• Ability to lift 50 pounds
• Understand PFMEA’s and Control Plans
• Working knowledge of Validation activities
• Design and Analysis of Experiments
• Knowledge of Lean Manufacturing
• Knowledge of Measurement System Analysis (Gage R & R)
• Process and Performance Capability Analysis
• Must possess excellent interpersonal skills, having the ability to interface with all levels of the organization, customers and suppliers
• Must possess organizational, analytical, planning and supervisory skills
• Knowledge of ISO 13485 and/or ISO-9001 International Quality System Standards
• Knowledge of the FDA’s QSR 21CFR part 820 Medical Device Standard
Responsibility/Authority
• Participate in Material Review Board (MRB)
• Participate in New Product Release Review (NPR)
• Create inspection plans for new and existing product
• Provide Quality support through manufacturing process
• Facilitate Corrective and Preventative Actions
• Facilitate Validation activities
• Create and maintain PFMEA’s and Control Plans
• Understand and Implement Customer Specific Requirements
• Facilitate Customer Audits
• Program inspection equipment
• Write/Up-date Work Instructions
• Use statistical tools to analyze data, make recommendations and improve process capability.
• Develop, implement and maintain a Statistical Process Control program
• Perform special projects and assignments as defined by the Quality Manager
• Evaluate and improve inspection systems/procedures. Design and implement new inspection methods and improve current inspection methodology
• Work with customers and suppliers to standardize inspection methods
• Perform process capability analysis and recommend improvements
• Perform Gage R&R studies and recommend improvements
• Perform Vendor Audits
• Supplier Quality
• Train employees as needed
Supervisory Responsibilities
• None