Quality Assurance Quality Control Engineer

Location:

Folsom, CA (preferred) or Remote (U.S.)

Type:
Full-time

HiDO Health is building an AI-enabled robotics platform that brings verified medication adherence into the home, addressing a critical gap in care for chronic disease and dementia patients. Backed by NIH funding and clinical partnerships, HiDO is focused on delivering real‑world impact outside traditional healthcare settings.

We are hiring a QA/QC Lead to own quality and compliance execution at HiDO Health. This is a hands‑on documentation and testing role inside an established quality system. HiDO already operates a working QMS — controlled procedures, an active CAPA system, risk management file, supplier quality processes, and an executed QC test corpus across the platform's hardware, firmware, and software. You will read what exists, find what is missing, write what is needed, and execute the tests that prove the product meets its requirements.

You will work directly with leadership, engineering, and manufacturing partners, plugging into a tiered approval hierarchy. This is not a policy or advisory role. You will produce the work product: protocols, records, results, and the documents that tie them together.

• Read and interpret HiDO's existing QMS (controlled procedures, work instructions, forms, templates) and identify gaps, inconsistencies, and outdated references
• Author and revise SOPs, work instructions, forms, and templates in HiDO's established document style and periodic review
• Keep cross‑references between procedures, records, and the DHF/DMR/DHR accurate

• Pick up and operate HiDO's existing QC test infrastructure across the dashboard, onboarding portal, patient mobile app, caretaker mobile app, firmware, and hardware
• Write test protocols, test cases, and acceptance criteria traceable to design inputs
• Execute verification and validation tests and record results in a form that survives audit
• Run incoming, in‑process, and outgoing QC checks against documented criteria
• Investigate test failures, document deviations, and drive corrective action through to closure

• Maintain the Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR)
• Maintain risk management documentation under ISO 14971 alignment
• Keep traceability intact from user needs through design inputs, outputs, V&V, and post‑market activities
• Support clinical study documentation as needed (HiDO has an active dementia‑population study with a university partner)

• Align quality documentation and processes with the contract manufacturer
• Ensure production documentation is complete, usable on the floor, and matches the DMR
• Operate practical incoming and outgoing QC processes
• Maintain supplier qualification documentation and quality agreements

• Maintain alignment with current Class I (510(k)-exempt) requirements under 21 CFR Part 820.
  
  Note:
  
  HiDO's regulatory pathway is under active review and may evolve toward Class II Special Controls under De Novo. The candidate should be comfortable working in both states.
• Operate the existing CAPA and complaint‑handling systems
• Prepare documentation for internal audits and partner/investor diligence

• 3–6+ years in medical device QA/RA, quality engineering, or compliance
• Demonstrated ability to read and interpret existing QMS documentation and find what is missing or wrong
• Demonstrated ability to write SOPs, work instructions, and test protocols that hold up under review
• Hands‑on experience designing and executing verification, validation, or QC tests, and recording results to a controlled format
• Working knowledge of IEC 62304 (medical device software lifecycle) and IEC 62366‑1 (usability engineering)
• Experience contributing to or maintaining a QMS
• Ability to operate independently and execute without close supervision

• Experience with contract manufacturers
• Experience with hardware‑plus‑software or connected devices
• Experience writing or executing software test cases under IEC 62304
• Familiarity with…