Design Quality Engineer

Job Summary

Quantum Surgical is looking for a Design Quality Engineer to join a team of creative and energetic people who are building the next generation platform to process minimally invasive therapies.

The Design Quality Engineer performs quality/reliability engineering activities to ensure that the design/development procedures, design controls, supplier controls an test requirements are fulfilled according to Quantum Surgical procedures and regulatory requirements.

The candidate should have a demonstrated experience in medical device industry.

Key Responsibilities

  • Support the creation and review of design inputs, outputs and validation documentation per regulatory guidelines and act as an objective reviewer to review the content of the document and ensure product development adheres to regulatory guidelines.
  • Review related project deliverables such as : design verification and design validation protocols and reports as well as process validation protocols and reports.
  • Work with Engineering & Manufacturing department in the validation of process, software for QMS and equipment.
  • Participate to the elaboration of the Regulatory submission file.
  • Participate in the continuous improvement of the quality engineering system.
  • Ensure compliance with Quantum Surgical quality and regulatory policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance and regulatory principles.
  • Support post market activities as necessary such as Corrective and Preventive action projects related to identified design issues, support in conducting root cause analyses, preparation of CAPA, complaints and Distributed Product Risk Assessment.
  • Follow and maintain quality system policies and procedures to ensure that products and processes meet applicable standards and specifications.
  • Perform other functions related to QMS implementation and maintenance as required.

Experiences and Qualifications

  • MS Engineering (Biomedical, Science, Mechanical) or equivalent
  • 5+ years of experience in a quality engineering position in the Medical Device Industry
  • Knowledge and application of quality systems, design controls
  • Knowledge of main applicable regulations and standards (ISO 13485, ISO 14971, IEC 60601-1; IEC 62366, IEC 62304, FDA 21 CFR 820, FDA guidelines)
  • Ability to work across functions and team boundaries
  • Solid analytical and problem-solving skills
  • Pragmatic
  • Excellent communication and documentation skills
  • Proficient in oral and written English

Desired Experience