Quality Engineer Jobs

About The Position

Requirements

• Bachelor’s degree in Biomedical Engineering, Software Engineering, Mechanical Engineering, or a related technical field.
• 5+ years of design quality engineering experience within the medical device or digital health industry.
• 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.
• Direct experience building and implementing an ISO 13485 QMS.
• Deep, hands-on proficiency in Design Controls, Risk Management (ISO 14971), CAPA management, Complaint Handling, and Post-Market Surveillance (PMS).

Nice To Haves

• Direct experience or working knowledge of the FDA’s updated Quality Management System Regulation (QMSR).
• Experience with Software as a Medical Device (SaMD) and/or software in a medical device (SiMD), firmware/hardware integration, human factors validation, and cybersecurity.
• Direct involvement in successful FDA submissions or European CE mark technical files.
• ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Six Sigma Green/Black Belt.

Responsibilities

• Lead the design, implementation, and roll-out of an ISO 13485-compliant Quality Management System.
• Establish and standardize core quality procedures, including document control, change management, CAPA, nonconformance, and audit readiness.
• Ensure organizational alignment with ISO 13485 and prepare the company for FDA Inspections/Notified Body audits.
• Establish and execute end-to-end complaint handling processes, root-cause investigations, and medical device reporting (MDR) evaluations.
• Drive the CAPA and Nonconformance (NC) processes, performing thorough root-cause analyses and implementing corrective/preventive actions.
• Design and maintain the Post-Market Surveillance (PMS) system, generating PMS reports, clinical evaluation updates, and data trending summaries.
• 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.
• 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.
• 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.

Benefits

• Meaningful employee stock options
• 100% company-paid medical, dental, and vision coverage
• 401(k)
• Competitive time off with pay policies including vacation, sick days, and company holidays