Quality Assurance Quality Control Engineer

QA/QC Lead — Medical Device

Hands-On, Startup Execution

Company: HiDO Health

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

Type: Full-time

About HiDO Health

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.

Role Overview

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, a 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.

What You'll Own

Documentation — Reading and Writing

• 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forms, templates) and identify gaps, inconsistencies, and outdated references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

• Operate document control: versioning, approval routing, change history, training records,

and periodic review

• Keep cross-references between procedures, records, and the DHF/DMR/DHR accurate

as documents evolve

Test Design and Execution

• 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 and

risk controls

• 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

Design Controls and the Technical File

• 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)

Manufacturing and Supplier Quality

• 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

Compliance and Readiness

• 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

What We're Looking For

Must-Have

• 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:

◦ 21 CFR Part 820

◦ ISO 14971 (risk management)

◦ IEC 62304 (medical device software lifecycle)

◦ IEC 62366-1 (usability engineering)

◦ Design controls (DHF, DMR, DHR)

• Experience contributing to or maintaining a QMS

• Ability to operate independently and execute without close supervision

Nice-to-Have

• Experience with contract manufacturers

• Exposure to ISO 13485

• Experience with hardware-plus-software or connected devices

• Experience writing or executing software test cases under IEC 62304

• Familiarity with 21 CFR Part 11 (electronic records and signatures)

• Familiarity with AAMI TIR45 (agile development for medical device software)

• Familiarity with AAMI TIR57 and/or FDA premarket cybersecurity guidance for

connected devices

• Exposure to ISO 27001, HIPAA Security Rule, or healthcare data protection in a cloud

environment

• Startup or small company experience

• Certifications: ASQ CMDA, CQA, CQE, or CSQE; RAPS RAC; ISO 13485 Lead

Auditor

What Success Looks Like (First 90 Days)

• Existing QMS read end-to-end, with a documented gap list

• Document control mechanics in working order

• Existing artifacts organized into DHF/DMR structure with traceability intact

• A working test protocol and execution cadence in place for the current build

• Alignment with the manufacturing partner on quality documentation

• A clear path to audit readiness

Compensation

• Base Salary: $90,000 – $110,000

• Benefits: Health

• Location: Folsom, CA

Why This Role Matters

This role is the quality foundation under everything else HiDO does — scaling manufacturing,

supporting clinical and commercial partnerships, and keeping the company compliant and

operationally disciplined.

How to Apply

Please include a brief note describing your experience with QMS documentation (both reading

and authoring), design controls (DHF/DMR/DHR), and medical device test design and

execution, along with your resume.