Responsible for evaluating, defining, implementing and monitoring quality management systems, tools and procedures applicable to production lines to ensure compliance with product and customer requirements and specifications.
- Identifies customer and technical product requirements, safety features, product and process criticalities, pass through.
- Works with Engineering for interpretation of product and process specifications, defines process controls with the team, serves as liaison between Plant and Customer when necessary.
- Implements, validates, maintains and improves process and equipment controls to meet product and customer requirements and verifies compliance and performance over time.
- Participates in the different stages of the APQP process and prepares corresponding documentation such as process control, first part validation, red rabbits, rabbit and work instructions.
- Is directly responsible for the elaboration and update of Core Documents (control plans, first part validation, GP12/ EPC, red rabbits, rabbit test and co-responsible for Process Flow, PFEMA, Operating Instructions) through periodic reviews and/or audits.
- Prepares RFQs for modifications and new equipment.
Evaluates vendor capabilities.
- Ensures compliance with the requirements contracted with the manufacturer of the means of production from technical clarification, follow up on commitments and dates and scope of work in relation to controls, go/nogo gauges, red rabbits, rabbit test sequences, repairs, disassembly, etc.
- Performs and coordinates design validations, FAT and SAT validations of process and test equipment through statistical analysis, validation runs, preliminary runs, pilot runs, error and mistake proofings in terms of CPK, GR&R.
- Leads, collaborates with the multidisciplinary team the preparation of resources and actions for a successful start of production (SOP) and a robust GP12 / EPC.
- Main communication contact with the customer on quality aspects, specific requirements and customer satisfaction.
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