Quality Engineer

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

Responsibilities

• Support new business development
  • Draft preliminary Quality Plan, if appropriate
  • Provide cost and time estimates for anticipated quality department services such as metrology or validation services
  • Function 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
  • Review new program drawings/information/customer specifications to understand program requirements
  • Determine quality and reliability standards and ensure dimensional and cosmetic requirements, as well as customer specifications, are defined and understood
  • Draft 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
  • Draft other required quality documentation such as Dimensional Visual Quality Requirements (DVQRs) and new product inspection techniques
  • Confirm customer agreement on GD&T callouts/interpretations and all critical dimensions of program when required
  • Prepare Failure Mode Effects Analysis (FMEA), as needed
  • Prepare Traveler Document
  • Develop required Control/Test methods
  • Ensure First Article Inspection (FAI) and Capability Studies are scheduled and completed
  • Complete FAI and capability study analysis for submission to customer
  • Author operational qualification (OQ) and performance qualification (PQ) protocols and provide training for protocol participants
  • Oversee the execution of assigned OQ and PQ studies to ensure compliance with protocol requirements and completion of study tasks
  • Author OQ and PQ Completion Reports to include resolution of any deviations recorded and overall study conclusion
  • Establish golden sample standards and prepare and submit to customer via customer approval form (CAF) as required
  • Attend program team meetings to address quality-related matters
  • Perform assigned activities in a timely manner
• Provide continuous quality engineering support through program end of life
  • Complete Certificates of Conformance (CoC) for outgoing products, where required
  • Collect and analyze production line data to monitor yield and defect performance
  • Ensure golden samples are retained and controlled
  • Maintain Device History Records (DHR) as necessary
  • Perform periodic risk assessments, as required
  • Assist Purchasing Department with maintaining vendor quality requirements
  • Continuously monitor production to identify quality-related customer issues and support corrective action plans when necessary
  • Issue or authorize CCRs as needed. Manage the return of goods, assignments, and close out of RC/CA
  • Conduct root cause investigation and develop corrective action plans for assigned problem reports (PSRs) and quality issues
  • Manage product and process change control and notification to ensure required Engineering Change Orders (ECOs) are generated and approved by the customer prior to implementation
  • Attend program team meetings as necessary to resolve program quality issues to maintain customer satisfaction
  • Support QBRs with customer and provide/present quality-related topics
  • Participate in customer, certified body, and regulatory audits as a subject matter expert for assigned products and processes
• Occasional domestic travel required
• Working knowledge of statistical techniques and sampling plans and of Quality Systems Regulations and ISO Standards
• Other duties as assigned

Requirements

• High school diploma with five years related experience, or
• Associate’s degree (A.A.) or equivalent from two-year college or technical school with three years related experience, or
• Bachelor’s degree (B.S.) in a technical (STEM or Engineering) field, with zero to one year related experience
• Experience in a 21CFR Part 820 or ISO 13485 quality system environment strongly preferred