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Quality Engineer, Sustaining Product Quality

Company: Orchid Orthopedics
Location: Saginaw
Posted on: August 4, 2022

Job Description:

SUMMARY OF POSITION
The Quality Engineer II 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.

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

WHAT YOU WILL DO

  • 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.
  • Leads the development of essential QMS deliverables including, but not limited to: complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification/validation
  • Leads 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.
  • Leads pre- and post-production reviews providing quality engineering support.
  • Performs quality reviews and internal audits; evaluates data and writes associated reports. Reviews other quality team members' reports and provides feedback
  • 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.
  • Leads measuring and analyzing key metrics to monitor performance.
  • Leads cross-functional teams to solve production and quality problems.
  • Creates and manages the overall course structure and sets up course programs based on specifications.
  • Provides input to the management team on establishing quality goals, collects the required data and charts progress toward the established goals
  • Identifies and supports measuring and analyzing key metrics to monitor performance as well as productivity improvements providing quality guidance
  • Acts on behalf of the Manager, Sustaining Product Quality when he/she is not present at the site
  • Create all CMM programming (including updating and revision control), gauge designs to release to QA, First Article Layouts, and Inspection plans to ensure adequate control of product
  • Develop tool specification to ensure dimensional optimization - contraction/bias/design
  • Liaise with Quality Assurance on Control Plans and with Engineering on tool construction, tool build and gauge design
  • Hire, train, assist employees; handle complaints, discipline and changes in status; set performance standards; conduct performance reviews; provide information regarding company.
  • 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
    7+ Years of Experience in Medical Device Manufacturing, 7+ Years of Related Experience (Required), Management/leadership Experience

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

    CERTIFICATIONS
    Any - Quality Certification, GD&T - Any

    KNOWLEDGE & SKILLS THAT ENABLE SUCCESS
    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)

    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

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

        Constantly operates a computer

        Occasionally inspects and places parts

        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, Saginaw , Quality Engineer, Sustaining Product Quality, Engineering , Saginaw, Michigan

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