Quality Engineer - CP​/FMEA

Summary

Responsible for the creation, implementation, maintenance, and continuous improvement of Process FMEAs, Control Plans, part-history records, Babtec quality inspections, gage and calibration management, and Measurement System Analysis activities. Ensures quality-planning documents and inspection systems accurately reflect current manufacturing processes, product requirements, customer-specific requirements, identified risks, required controls, inspection methods, and reaction plans.

• Serve as the primary owner of the company’s PFMEA, Control Plan, Part History, Babtec Inspection, Gage Management, Calibration, and MSA systems.
• Lead the creation, development, implementation, revision, and annual review of PFMEAs and Control Plans for new and existing products and manufacturing processes.
• Lead cross-functional PFMEA and Control Plan reviews with applicable representatives from Quality, Production, Maintenance, Tool & Die, Logistics, Purchasing, Engineering, and other responsible departments.
• Ensure PFMEAs accurately identify process steps, potential failure modes, effects, causes, prevention controls, detection controls, product/process characteristics, reaction plans, and required risk-reduction actions.
• Ensure PFMEA controls are properly transferred into the applicable Control Plan and that PFMEA, Control Plan, process flow, work instructions, Babtec inspections, and actual production processes remain aligned.
• Verify all applicable drawing requirements, specifications, customer-specific requirements, special characteristics, internal requirements, lessons learned, and corrective actions are incorporated into quality-planning documents.
• Ensure Control Plan characteristics clearly define the applicable specification/tolerance, measurement method, gage or equipment, sample size, inspection frequency, control method, and reaction plan.
• Create and maintain part-history records documenting significant drawing revisions, process changes, tooling/equipment changes, material changes, customer complaints, internal concerns, corrective actions, deviations, scrap/rework concerns, and lessons learned.
• Initiate PFMEA and Control Plan reviews when significant product, process, material, tooling, equipment, inspection, customer, quality, or engineering changes occur.
• Create, revise, approve, and maintain Babtec quality inspections for applicable incoming, production, coating, safe-launch, enhanced-inspection, and other required inspection stages.
• Ensure Babtec inspections contain accurate inspection questions, specifications, tolerances, measurement methods, required gages, sample sizes, frequencies, visual standards, reaction plans, reference documents, and data-entry requirements.
• Ensure Babtec inspections remain aligned with current drawings, PFMEAs, Control Plans, process flows, work instructions, customer requirements, and special-characteristic requirements.
• Review similar Babtec inspections to ensure consistent inspection wording, methods, frequencies, acceptance criteria, and reaction requirements unless a documented part-specific difference exists.
• Validate new and revised Babtec inspections with the employees responsible for performing the inspections before final release and provide applicable training or clarification.
• Conduct periodic reviews of inspection execution to verify employees are performing inspections according to approved Babtec requirements and correct unclear, obsolete, duplicate, or conflicting inspection requirements.
• Serve as the primary administrator of the company’s gage and calibration management system, including gage identification, ownership, location, calibration status, verification requirements, and system records.
• Create and maintain Babtec gage records for reference gages, externally calibrated equipment, inspection fixtures, master samples, CMM/check fixtures, Instron equipment, and other monitoring and measurement devices.
• Establish calibration and verification frequencies based on equipment type, manufacturer recommendations, usage, historical performance, measurement risk, customer requirements, and internal requirements.
• Coordinate external calibration activities, including scheduling, equipment collection, shipment, receipt, certificate review, record retention, and return to service.
• Review calibration certificates for equipment identification, results, traceability, applicable standards, acceptance status, out-of-tolerance conditions, and calibration-provider…