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Quality Engineer, Sustaining Product Quality

Company: Orchid Orthopedics
Location: Gresham
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, Gresham , Quality Engineer, Sustaining Product Quality, Engineering , Gresham, Oregon

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