Quality Systems Manager at Axiobionics
Quality Assurance · Full-time
Ann Arbor, MI, USA
USD 25-35 / hour
Posted on Jul 8, 2026
Axiobionics LLC | Ann Arbor, Michigan
About Axiobionics
Axiobionics designs and manufactures wearable functional electrical stimulation (FES/NMES) devices that help people recover movement and independence after stroke, spinal cord injury, traumatic brain injury, and other neurological conditions — including children with cerebral palsy. Our product line, including the BioSleeve, BioShorts, TripleFlex, WalkAide, and the NeuroPro 8i controller, is built on decades of clinical research and real patient outcomes. We're a small, mission-driven medical device company based in Ann Arbor, and quality isn't a department here — it's the foundation everything else stands on.
Position Summary
We're looking for a Quality Systems Manager to own and run our quality management system end to end. This is a hands-on role at a small, growing medical device company — you'll be doing the day-to-day work of the QMS yourself (not just directing a large team), while also owning its long-term health, audit-readiness, and continuous improvement. You'll touch nearly every function in the company, from design and manufacturing to purchasing and supplier relationships, and you'll be the person who makes sure our devices are safe, effective, and fully compliant with FDA and international requirements at every stage.
This role suits someone who is comfortable wearing many hats, thrives on process and documentation, and takes genuine pride in building systems that protect patients.
Key Responsibilities
Quality Management System (QMS)
● Maintain, administer, and continuously improve the QMS in accordance with FDA 21 CFR Part 820 (Quality System Regulation / QMSR) and ISO 13485
● Own document control: SOPs, work instructions, forms, and records — creation, revision, approval routing, and archival
● Plan and conduct internal audits; track findings through to closure
● Prepare for and host external audits and FDA inspections; serve as primary quality point of contact
● Lead or support periodic management review meetings with quality metrics and trending data
Design Controls & Risk Management
● Maintain Design History Files (DHF), Device Master Records (DMR), and Design Input/Output documentation for all products
● Support design changes and new product development with appropriate design control rigor (design reviews, verification, validation)
● Maintain risk management files per ISO 14971, including FMEAs and risk/benefit analyses
Change Control
● Own the Engineering Change Order (ECO) process from initiation through implementation and documentation closure
● Assess the quality, regulatory, and risk impact of proposed changes to devices, processes, and suppliers
● Ensure change records are complete, traceable, and audit-ready
Supplier Quality
● Maintain the Approved Supplier List and manage supplier qualification, requalification, and periodic evaluation
● Conduct or coordinate supplier audits and assessments as needed
● Manage supplier corrective actions (SCARs) and incoming inspection criteria
Nonconformance, CAPA & Complaints
● Manage the CAPA (Corrective and Preventive Action) system, including root cause investigation and effectiveness checks
● Own the nonconforming material process, including disposition and trending
● Manage complaint handling and determine reportability under MDR (Medical Device Reporting) requirements
Operations, Inventory & Day-to-Day Quality
● Support receiving inspection, in-process, and final device inspection/testing activities
● Maintain quality oversight of ordering, inventory control, and lot/serial traceability
● Maintain calibration and preventive maintenance records for measurement and production equipment
● Maintain training records and support quality-related training for staff
● Handle the many recurring quality tasks that keep a small medical device company running compliantly day to day
What You'll Need
● 3+ years of experience in a Quality role within the medical device industry, with direct working knowledge of 21 CFR Part 820 and ISO 13485
● Hands-on experience with design controls, risk management (ISO 14971), CAPA, and supplier quality
● Experience preparing for and participating in FDA inspections and/or third-party audits
● Strong document control discipline and comfort owning a QMS with real accountability, not just administering someone else's
● Highly organized self-starter, comfortable being the sole or lead quality function at a small company
● Clear written communication for SOPs, reports, and audit responses
● Bachelor's degree in a relevant technical, scientific, or engineering field preferred
Nice to Have
● ASQ certification (CQM/OE, CQA, or similar)
● Experience with electrical/electronic medical devices or wearable technology
● Familiarity with 510(k) submissions or FDA Pre-Submission processes
● Experience in a small company/startup environment where quality wears many hats
What We Offer
● A central, high-impact role at a mission-driven company improving quality of life for people with physical disabilities
● Direct ownership of the quality function, with real influence over how the company operates
● A small, close-knit team where your work is visible and valued
● Benefits — Healthcare benefits
Axiobionics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Axiobionics, LLC is an equal opportunity employer.