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Design Quality Engineer

Leetsdale, Pennsylvania 15056 | Direct Placement

Post Date: 03/15/2018 Job ID: 75431 Category: Design Engineers

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Design Quality Engineer   is accountable to support the quality system by ensuring compliance to and enforcing regulations, standards, policies, standard operating procedures, and instructions related to design control. The Design Quality Engineer  will work as a member of the cross-functional design team supporting new product development and sustaining engineering change management.

Responsibilities/Essential Duties:

Support New Product Development and Product Change Management
  • Represent Quality department as cross-functional team member for product portfolios, new product development projects, and product change projects.
  • Review project quality plans.
  • Participate in translation of Voice-of-Customer into development requirements.
  • Support development team in creation, review, and approval of engineering requirements & specifications in accordance with standard operating procedures.
  • Support cross-functional teams in the development, update, and release of risk management documentation inclusive of but not limited to:  Hazard Analysis, Risk Management Plan & Report, FMEA’ s (Use, Design & Process), Fault Tree Analysis (FTA).
  • Review and approval of engineering development plans & test plans.
  • Review and approval of engineering test protocols and reports in support of design verification, design validation, and process validation.
  • Review and approval of critical-to-quality specifications.
  • Support development team in creation, review, and approval of traceability of user requirements, engineering specifications, and verification & validation testing.
  • Review measurement systems analysis for acceptability and approve validation protocols and reports for test methods.
  • Provide support and guidance on statistical testing methods and sampling in support of verification and validation testing.
  • Support 1 Product Line Portfolio.
  • Ensure accuracy and completeness of the Design History File and the Device Master Record.
  • Compile, review, and analyze failure data to provide feedback to the development team.

Support Quality System
  • Ensuring compliance to and enforcement of all required elements from regulations, standards, policies, standard operating procedures, and instructions.
  • Supporting and administering quality system elements including but not limited to:  Design Controls, CAPA, Non-Conformance, Complaint, Deviation, Document Controls, Labeling, etc.
  • Provide feedback and review of policies, procedures, instructions, and training.
  • Support any potential internal/external audits and inspections.
  • Participate in problem solving and other work improvement activities.

  • BS Degree in Electrical, Biomedical, Mechanical or other equivalent technical engineering discipline.
  • 1-2 years of Quality Engineering, requires strong documentation skills in QSO,  ECO, writing protocols.
  • FDA or ISO experienced required. 

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