Senior Quality Engineer

Senior Quality Engineer (Direct Hire)


Job Requisition: 6594

Description for Senior Quality Engineer:
The Senior Quality Engineer will work closely with operations and engineering to address issues that can negatively impact our Customer Facing Metrics (OTD and PPM) and to reduce scrap and drive continuous improvement activities for the purposes of reducing customer complaints, lowering response time, and identifying and removing Non-Value-Added activities. This position will investigate internal and external quality issues and use statistical analysis and other tools to identify root cause and effective corrective actions.  This position is responsible for periodic reporting. This position is based in the Washington, NC, manufacturing location and reports to the Quality Manager.

Responsibilities for Senior Quality Engineer:
  • Customer Advocate
    • Able to independently interact with customers to seek information, present ideas or address concerns.
    • Provides appropriate customer communications as required in response to inquiries and/or quality feedback.
  • New Product Development
    • Participate in Design Reviews, including Technical Reviews, Feasibility Discussion, and Failure Modes and Effects Analysis (FMEA) creation
    • Assist in documenting development work including supporting writing specifications for manufacturing or identifying and/or evaluating scientific test results
    • Manage Implementation and Documentation of IQ, OQ, PQ.
    • Ensure timely and conclusive validations.
  • Process Control
    • Update existing inspection plans, test methods, and standard operating procedures
    • Conduct sample size determination, statistical analysis, training, and root cause analysis
    • Take lead in understanding/updating FMEA for new failure modes
    • Assist in process optimization
  • Continuous Improvement 
    • Drive and Actively contribute to various manufacturing projects such as process development, cost reduction and quality improvement initiatives
    • Perform routine engineering assignments of related tasks which are typically a focused portion of larger projects. 
    • Lead cross-functional teams in continuous quality improvement projects, in particular, in scrap reduction and identification and elimination of non-value-added activities
    • Take lead in collection, review, analysis and trending of quality indicators for monthly and quarterly reviews
    • Manage and contribute to problem solving teams using standardized investigation processes/tools.
    • Evaluate for potential contributors to product defects and/or production delays for the purpose of addressing and correcting them.
  • Compliance
    • Participate in the Internal Audit process and assist in addressing observations
    • Participate in customer and regulatory body audits
  • Other tasks and duties assigned

Requirements for Senior Quality Engineer:
  • Bachelor's degree in Engineering (Mechanical, Plastics, Biomedical) required
  • A minimum of 3+ years related work experience required
  • Previous experience with product design in Plastic Injection molding in a high-volume manufacturing environment required. 
  • Injection mold tooling design experience preferred
  • Fluency in 3D CAD (Solidworks preferred)
  • Working understanding of part design layout and GD&T
  • Understanding of DFMEA & PFMEA methodology and approach
  • Uses advanced analysis tools and methods to solve complex technical problems (e.g. 3-D Modeling and Design, Computational Fluid Dynamics, and Finite Element Analysis). 
  • Mold-flow analysis experience is a plus
  • Ability to independently test, analyze and solves technical problems
  • Experience with medical device manufacturing strongly preferred.
  • Previous experience in Infusion Disposables a plus
  • Must exhibit excellent organizational skills and be detail oriented
  • Ability to work independently and with cross-functional teams
  • Effective oral, interpersonal, and written communication skills.
  • Self-directed with creative problem-solving ability
  • Ability to train and coach others from technical expertise

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