Principal Design Quality Assurance Specialist

2 weeks ago


Santa Clarita, California, United States huMannity Medtec Full time
Principal Design Quality Engineer

We are seeking an experienced Principal Design Quality Engineer to join our Quality Assurance team at huMannity Medtec. As a key member of our team, you will play a critical role in ensuring the development and demonstration of our life-enhancing medical technologies meet the highest standards of quality and regulatory requirements.

Main Responsibilities:
  • Lead risk management activities, including the creation and maintenance of risk management documentation, such as FMEAs, hazard analysis, plans, reports, and trace matrices in accordance with ISO 14971 and cybersecurity requirements.
  • Actively support the creation and approval of technical documentation for medical devices, specifically, implantable medical systems, including Requirements, Specifications, V&V plans, reports, and manufacturing documentation.
  • Represent the Quality Organization on Product Development teams. Support the design control activities required for early design feasibility studies design. Provide critical feedback to project teams during the document review and approval process.
  • Develop quality assurance specifications, inspection procedures, test methods, sampling plans, and written procedures.
  • Prepare technical documentation to support design control activities and regulatory submissions.
  • Collaborate with R&D and Manufacturing Engineering in the creation of design and manufacturing documentation to establish the pilot production processes and procedures required to support early feasibility studies.
  • Drive improvements in quality system processes and procedures.
  • Support the assigned CAPA and supplier quality activities by implementing effective solutions.
Requirements:
  • Bachelor's degree and 8+ years of experience in the medical device industry, Class III preferred.
  • Demonstrated command and knowledge of FDA and ISO medical device quality system requirements (21CFR820, ISO 13485, and ISO and audit programs (MDSAP).
  • Demonstrated ability to support multiple projects.
  • Experienced leading design assurance activities for new product development.
  • Proficient computer skills including MS Word, Excel, Teams, Outlook, and statistical software (e.g., MiniTab, Design of Experiment DOE, etc.).
  • ASQ Certified Quality Engineer (CQE), preferred.


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