Senior Design Quality Assurance Engineer

hace 5 días

Tijuana, Baja California, México Haemonetics Corp. A tiempo completo
About the Role

We are seeking a highly skilled Senior Design Quality Assurance Engineer to join our team at Haemonetics Corp. This is an exciting opportunity for a talented professional to contribute to the development and implementation of quality assurance strategies that drive business growth and excellence.

Key Responsibilities
  • Support the quality system by ensuring compliance to and enforcing regulations, standards, policies, standard operating procedures, and instructions related to design control.
  • Work as a member of the cross-functional design team to support new product development and sustaining engineering change management.
  • Represent the Quality department as a cross-functional team member for product portfolios, new product development projects, and product change projects.
  • Manage project quality plans, lead or participate in the translation of Voice-of-Customer into development Requirements, and support the development team in creating, reviewing, and approving engineering Requirements & Specifications.
  • Lead cross-functional teams in the development, update, and release of risk management documentation, including Hazard Analysis, Risk Management Plan & Report, FMEA's (Use, Design & Process), and Fault Tree Analysis (FTA).
  • Support the development team in creating, reviewing, and approving engineering development plans & test plans, as well as engineering test protocols and reports in support of design verification, design validation, and process validation.
  • Lead the development team in creating, reviewing, and approving critical-to-quality specifications and support the development team in creating, reviewing, and approving traceability of user requirements, engineering specifications, and verification & validation testing.
  • Lead measurement systems analysis for acceptability and develop, support, and approve validation protocols and reports for test methods.
  • Define statistical testing methods and sampling in support of verification and validation testing.
  • Support any Product Line Portfolios and actively support 1 or more Product Line Portfolios.
  • 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.
  • Mentor, develop, coach, and/or supervise less experienced quality engineers.
Quality System Support
  • Ensure compliance to and enforcement of all required elements from regulations, standards, policies, standard operating procedures, and instructions.
  • Support and administer quality system elements, including Design Controls, CAPA, Non-Conformance, Complaint, Deviation, Document Controls, Labeling, etc.
  • Lead continuous improvement projects and reviews of policies, procedures, instructions, and training.
  • Ensure the ongoing readiness for and participate in any potential internal/external audits and inspections.
  • Lead or participate in problem-solving and other work improvement activities.

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