Job Summary
- Location
- Houston, PA 15342
- Industries
- Medical Devices and Supplies
- Job Type
- Full Time
- Employee
- Years of Experience
- 5+ to 7 Years
- Education Level
- Bachelor's Degree
- Career Level
- Experienced (Non-Manager)
- Job Reference Code
- 3534
Quality Engineer-Calypso
About the Job
This position is required in order to plan and validate processes from the quote and contract review stage through shipment to ensure the product meets customer requirements in all respects. The incumbent will determine and clarify customer inspection requirements and develop, use, and improve our quality system to meet those requirements.
Key Result Accountabilities
1. Continuous Improvement: Identify and validate process controls on key production processes to assure consistent and repeatable process outputs. Seek new inspection methods with inspection equipment providers/vendors. Work with toolmakers/R&D to design new and/or improved inspection gauging or fixturing. Provide sponsorship and act as change facilitator for SPC, FMEA, DOE, and process validation systems with the net result of inspection velocity. Innovate and improve the quality system to achieve a Best in Class medical device process development system.*
2. Process Validation: Develop and implement IQ, OQ, and PQ protocols to ensure
compliance with the Quality System.*
3. Quality System Metrics: Develop methods and systems to provide quality indicators to the organization, training the organization on those methods and systems.*
4. Corrective and Preventative Action: Work with customers and vendors to complete root cause analysis and to determine and implement Corrective and Preventive Actions. Perform trending of quality indicators, both internal and external, and lead continuous improvement efforts relating to our indicators.*
5. Training: Train production personnel on the Quality System and FDA requirements.*
6. Contract Review: Participate in quote and PO review process to identify unclear, incomplete or difficult requirements prior to engineering the product. Assist engineering Team in interpreting all types of blueprints, standards, and customer specifications into engineering requirements for implementation in Accellent Work Instructions.*
7. Regulatory Compliance: Ensure we comply with FDA’s Quality System Regulation.*
8. Bring any questions on interpretation of conformance to the attention of the Quality Assurance Manager.*
9. Perform other duties as assigned by supervisory personnel.
Job Requirements:
Two years experience as a Quality Engineer in a medical devisce manufacturing environment requjired. Strong math skills and mechanical aptitude. Computer skills required. Strong organizational skills and the ability to multi-task. Attention to fine detail and tolerances required.
Req. Code : 3534
% of Travel Required : None
Shift/Hours : First Shift (Day)
