Quality Engineer, Sustaining Product Quality

Company: Orchid Orthopedics
Location: Hillsboro
Posted on: July 27, 2022

Job Description:

SUMMARY OF POSITION
The Quality Tech II is responsible for a variety of activities to ensure quality and compliance needs are met. S/he is responsible for manufacturing readiness quality planning, sustaining process quality, continuous improvement initiatives, and compliance adherence.

SHIFT
No Shift ($0) (United States of America)

WHAT YOU WILL DO

• Uses quality tools to implement improvements including: process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility, and trend analysis techniques.
• Acts as a customer liaison and processes customer quality complaints, as applicable.
• Collects, Analyzes, and Presents data using statistical methodology
• Assists suppliers with the interpretation of quality requirements, as applicable.
• Assists the development of essential QMS deliverables/Advanced Product Quality Planning (APQP) including, but not limited to: complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification / validation
• Plans and/or conducts process and equipment validations and special validations including installation qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Determines machine and/or process capability through planning and/or executing Process Capability studies
• Develops inspection criteria that connect customer requirements and manufacturing processes that include identification of key characteristics, associated sampling plans, and required gauging.
• Interfaces with appropriate customer contacts to clarify customer requirements
• Conceives and/or Leads productivity improvements and/or Continuous improvement projects
• Monitors engineering production processes and products for adherence to internal and external requirements and practices.
• Participates in pre- and post-production launch reviews providing quality engineering support
• Performs quality reviews and internal audits; evaluates data and writes associated reports
• Recommends modifications to existing quality or production standards, where applicable, to achieve optimum quality within limits of equipment capability.
• Reviews and approves product/process and document change requests.
• Reviews drawings to evaluate quality requirements including: correct application of geometric dimensioning and tolerance, proper use of process and material specifications, and key characteristics for inspection plans and gauging techniques.
• Supports measuring and analyzing key metrics to monitor performance.
• Works with cross-functional teams to solve production and quality problems.
• Reinforces safety expectations. Ensures safety operating practices are demonstrated. Reports issues/concerns to Supervisor.
• Support quality and compliance by adhering to all procedures, work instructions, and forms per the Quality Management Systems (QMS).
• Provides and documents training on standard of work instructions, policies, and procedures in a timely manner to ensure team members have the required knowledge and skills prior to performing work independently.
  
  WHAT WE ARE LOOKING FOR
  
  WORK EXPERIENCE
  3+ Years of Experience (Required), 3+ Years of Experience in a Manufacturing Environment, Experience in Medical Device Manufacturing
  
  EDUCATION
  Bachelor of Science (B.S) - Engineering Required, , ,
  
  CERTIFICATIONS
  Training - Any
  
  KNOWLEDGE & SKILLS THAT ENABLE SUCCESS
  Communication (Basic Knowledge), Computer Knowledge (Working Experience), Decision Making and Critical Thinking (Basic Knowledge), Flexibility & Adaptability (Basic Knowledge), GD&T (Working Experience), ISO 13485 (Working Experience), Manufacturing Industry (Working Experience), Mathematical Ability (Working Experience), Problem Solving (Working Experience), Quality Inspection Metrology Tools (Working Experience)
  
  WHAT WE OFFER
  
  • Opportunity to work in a growing company
  • Ability to help people live a longer, more active life
  • Comprehensive benefit package
  • Ability to work in an organization that values:
    • Integrity First: We do the right thing
    • Teamwork: We are one Orchid
    • Results: Our results matter
      
      PHYSICAL REQUIREMENTS
      
      
      • Must be able to remain in a stationary position. - Occasionally
      • Must be able to move about the inside of the building. - Constantly
      • Must be able to move equipment around the building. - Constantly
      • Must be able to ascend/descend stairs or ladders. - Frequently
      • Must be able to position oneself and move under/around/over equipment. - Constantly
      • Must be able to handle/adjust/inspect/position various items and equipment. - Constantly
      • Must be able to communicate and exchange information with others. - Frequently
      • Must be able to perform tasks that require repetitive handling/adjusting/inspecting/positioning of items and equipment. - Constantly
        
        ADDITIONAL REQUIREMENTS
        
        • Candidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirements
        • Candidates must be able to provide proof of eligibility to work in the United States through eVerify
          
          EOE, including disability/vets

Keywords: Orchid Orthopedics, Hillsboro , Quality Engineer, Sustaining Product Quality, Engineering , Hillsboro, Oregon