TransEnterix, Inc.

The Sr. Quality Engineer is responsible for activities associated with product support and product development processes at TransEnterix globally.  Ensures that all activities for product support and product development are followed and documented to provide a safe and effective product that meets customer needs.  This position focuses primarily on supporting the product support teams from design transfer, manufacturing, and post-market activities ensuring the quality objectives are understood and achieved.  The Sr. Quality Engineer shall ensure mechanical, electrical, and software systems used in development, manufacturing and as part of medical devices are established according to requirements. 

RESPONSIBILITIES

  • Drives risk management activities including creation and maintenance of risk management files by product and process.
  • Participates in the design change process by assisting with development and documentation of impact analyses related to design, process, suppliers, etc.
  • Contributes to the design and process verification and validation activities including definition and qualification of test methods, acceptance criteria, and statistical principles.  As applicable, coordinates activities with external test labs.
  • Qualifies suppliers through analysis of data and audits as required
  • Participate in the continuous improvement of the quality engineering system.
  • Responsible for applying quality engineering to product development from concept to market launch to meet business objectives.
  • Contribute to cross-functional activities that support business goals
  • Participate in the evaluation and assessment of competitive products, processes or new trends that could impact our business as needed
  • Ensure compliance with TransEnterix quality and regulatory policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance and regulatory principles.
  • All Other Essential Duties as directed

 

QUALIFICATIONS

  • Bachelor's degree in engineering discipline, or relevant experience
  • 8+ years in a quality engineering role in the Medical Device field
  • Knowledge of the standards related to medical device manufacturing, including ISO13485, 21 CFR Part 820 and ISO 14971 preferred
  • Understanding of design control, disciplined product development processes, regulatory, and quality requirements.
  • Solid understanding of approaches to work breakdown, prioritization, resource allocation, and problem-solving
  • Working knowledge of common quality tools (i.e. Cpk/Ppk, DOE, Quality Reporting, etc.).
  • Experience working in cross-functional teams
  • Experience with software design and validation for medical devices preferred
  • Equipment and process validations experience
  • ISO 13485 inspections and FDA inspections experience a plus
  • Self-starter with the ability to work towards goals with little day-to-day supervision.
  • Knowledge of engineering performance enhancement tools in the area of Design for Six Sigma preferred
  • ASQ Certified Quality Engineer preferred
  • ASQ Certified Reliability Engineer preferred
TransEnterix, Inc.
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