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Quality Engineer, Sustaining Product Quality

Company: Orchid Orthopedics
Location: Arcadia
Posted on: May 12, 2022

Job Description:

The Quality Engineer II (Sustaining Product Quality OR New Production Introduction) supports the ongoing quality of Orchid's legacy products and works with project management and manufacturing engineers to support new production introduction and ongoing validation.

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


  • 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.


    3+ Years of Experience (Required), 3+ Years of Experience in a Manufacturing Environment (Preferred), Experience in Medical Device Manufacturing (Preferred)

    Bachelor of Science (B.S) - Engineering Required, , ,

    Any - Quality Certification

    Accuracy and Attention to Detail (Working Experience), Communication (Basic Knowledge), Computer Knowledge (Working Experience), Final Inspection (Working Experience), Lean Manufacturing (Working Experience), Manufacturing Safety (Working Experience), Operational Functions (Working Experience), Problem Solving (Working Experience), Process Management (Working Experience), Production Part Approval Process (PPAP) (Working Experience), Production Runs (Extensive Experience), Quality Management (Working Experience), Statistical Analysis and Measurement (Working Experience)

    • 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


        Occasionally moves heavy equipment, boxes, and other materials and tools.

        Constantly operates a computer

        Occasionally inspects and places parts

        • 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 Associated topics: business, cost efficient, industrial engineer, manufacturing engineer, methods engineer, project, sap, supply, supply chain

Keywords: Orchid Orthopedics, Arcadia , Quality Engineer, Sustaining Product Quality, Engineering , Arcadia, California

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