Quality Engineer

Summary:

Provides quality engineering support during new business development, new program launches and for existing customer programs

• Support new business development
  • Provides support to new business development relating to quality matters as needed
  • Draft preliminary Quality Plan, if appropriate
  • Provides cost and time estimates for anticipated quality department services such as metrology or validation services
  • Functions as a resource for applicable ISO Program and QSR Program requirements
• Support Program Launch and Product Realization as functional department representative assigned to team and Program Manager
  • Reviews new program drawings/information/customer specifications to understand program requirements
  • Determines quality and reliability standards
    and ensures dimensional and cosmetic requirements, as well as customer specifications, are defined and understood.
  • Drafts program Quality Plan (as required) and metrology labor plan to include definition of required fixtures, calibration and metrology requirements and measurement methods needed to meet customer requirements for approval
  • Drafts other required quality documentation such as Dimensional Visual Quality Requirements (DVQR’s) and new product inspection techniques
  • Confirms customer agreement on GD&T callouts/interpretations and all critical dimensions of program when required
  • Prepares Failure Mode Effects Analysis (FMEA), as needed
  • Prepares Traveler Document
  • Develops required Control/Test methods
  • Ensures First Article Inspection (FAI) and Capability Studies are scheduled and completed
  • Completes FAI and capability study analysis for submission to customer
  • Authors operational qualification (OQ) and performance qualification (PQ) protocols and provides training for protocol participants
  • Oversees the execution of assigned OQ and PQ studies to ensure compliance with protocol requirements and completion of study tasks
  • Authors OQ and PQ Completion Reports to include resolution of any deviations recorded and overall study conclusion
  • Establishes “golden sample” standards and prepares and submits to customer via customer approval form (CAF) as required
  • Attends program team meetings to address quality-related matters
  • Performs assigned activities in a timely manner
• Provide continuous quality engineering support through program end of life.
  • Completes Certificates of Conformance (CoC) for outgoing products, where required
  • Collects and analyzes production line data to monitor yield and defect performance
  • Ensures golden samples are retained and controlled
  • Maintains Device History Records (DHR) as necessary
  • Performs periodic risk assessments, as required
  • Assists Purchasing Department with maintaining vendor quality requirements
  • Continuously monitors production to identify quality-related customer issues and supports corrective action plans when necessary
  • Issue or authorize CCR’s as needed. Manages the return of goods, assignments and close out of RC/CA.
  • Conducts root cause investigation and develops corrective action plans for assigned problem reports (PSRs) and quality issues
  • Manages product and process change control and notification to ensure required Engineering Change Orders (ECOs) are generated and approved by the customer prior to implementation.
  • Attends program team meetings as necessary to resolve program quality issues to maintain customer satisfaction
  • Support Q ’s with customer and provides/presents quality-related topics
  • Participates in customer, certified body, and regulatory audits as a subject matter expert for assigned products and processes
• Occasional domestic travel required
• Has a working knowledge of Statistical techniques and sampling plans and of Quality Systems Regulations and ISO Standards
• Other duties as assigned