Senior Design Quality Engineer

QMS Building & Implementation

• QMS Architecture: Lead the design implementation and roll-out of an ISO 13485-compliant Quality Management System.
• Process Creation: Establish and standardize core quality procedures including document control change management CAPA nonconformance and audit readiness.
• Compliance Standards: Ensure organizational alignment with ISO 13485 and prepare the company for FDA Inspections/Notified Body audits.

Post-Market Surveillance Complaints & CAPA

• Complaint Handling: Establish and execute end-to-end complaint handling processes root-cause investigations and medical device reporting (MDR) evaluations.
• CAPA Leadership: Drive the CAPA and Nonconformance (NC) processes performing thorough root-cause analyses and implementing corrective/preventive actions.
• Post-Market Surveillance (PMS): Design and maintain the Post-Market Surveillance (PMS) system generating PMS reports clinical evaluation updates and data trending summaries.

Design Controls & Product Development Support

• Support execution and maintenance of design control activities across the product lifecycle.
• Maintain Design History File (DHF) documentation for Circadia products.
• Assist with preparation and review of:
  • Design inputs and outputs
  • Risk management documentation
  • Verification and validation documentation
  • Design review records
• Track design control deliverables and coordinate documentation across teams.

Regulatory Submission Support

• Assist in preparation of FDA submission documentation (e.g. 510(k)).
• Support compilation and organization of testing documentation and reports.
• Track submission deliverables and supporting evidence.

Cross-Functional Collaboration

• Coordinate with R&D Engineering Customer Success Ops and Clinical teams to collect documentation and evidence.
• Support human factors validation and cybersecurity testing coordination.
• Assist with third-party testing documentation collection.

• Education: Bachelors degree in Biomedical Engineering Software Engineering Mechanical Engineering or a related technical field.

• Senior-Level Expertise: 5 years of design quality engineering experience within the medical device or digital health industry.

• Startup Track Record: Proven experience in a fast-paced environment where you built processes from scratch rather than executing existing ones and are comfortable owning ambiguous evolving work.

• QMS Implementation: Direct experience building and implementing an ISO 13485 QMS

• Subject Matter Ownership: Deep hands-on proficiency in Design Controls Risk Management (ISO 14971) CAPA management Complaint Handling and Post-Market Surveillance (PMS).

• QMSR Familiarity: Direct experience or working knowledge of the FDAs updated Quality Management System Regulation (QMSR).

• Digital Health / Hardware Software: Experience with Software as a Medical Device (SaMD) and/or software in a medical device (SiMD) firmware/hardware integration human factors validation and cybersecurity.

• Regulatory Submissions: Direct involvement in successful FDA submissions or European CE mark technical files.

• Certifications: ASQ Certified Quality Engineer (CQE) Certified Software Quality Engineer (CSQE) or Six Sigma Green/Black Belt.