Senior QA Manager

StimCardio Medical Inc.; Austin, Northern (TX, KY); Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

Competitive compensation

Benefits package

Innovative medical tech

Job summary

StimCardio Medical Inc. in Austin, TX is seeking a QA Manager to lead the Quality Management System and ensure compliance with ISO 13485 and FDA regulations across design controls, risk management, supplier quality, and manufacturing quality.

You will partner with R&D and operations to drive CAPA, audits, and continuous improvement, while overseeing document control, training, and supplier qualifications.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical field.
• 5–8 years of medical device QA or quality systems experience.
• Experience with ISO 13485, 21 CFR 820, and global medical device regulations.
• Prior experience supporting audits, CAPA, design controls, and supplier quality.

Responsibilities

• Maintain and improve the Quality Management System per ISO 13485 and 21 CFR 820.
• Support audits (internal and external) and CAPA investigations with root cause analysis.
• Manage design controls, risk management, and supplier quality activities.
• Coordinate with R&D and manufacturing to ensure compliant product realization.
• Maintain document control and training systems; support risk management files.

Skills

Cross-functional collaboration

Analytical thinking

Root cause analysis

Documentation systems

Regulatory knowledge

Problem solving

Effective communication

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

Electronic document management systems

Job description

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StimCardio is a fast-growing medical device company developing a breakthrough non-invasive therapy for atrial fibrillation (AFib).
Our novel wearable combines advanced cardiac monitoring with proprietary neurostimulation technology to deliver closed-loop, patient-centric AFib management.
We are a mission-driven, execution-focused team bringing meaningful innovation to patients and physicians. This is an exciting opportunity to join us at a pivotal stage and play a key role in shaping our clinical operations.

Position Overview

The QA Manager supports the development, maintenance, and continuous improvement of the Company’s Quality Management System in alignment with FDA regulations, ISO 13485, and international medical device requirements. This role reports to and works closely with the VP of RA/QA to implement quality processes, coordinate cross-functional activities, and ensure disciplined execution across Design Controls, Risk Management, Supplier Quality, and Manufacturing Quality. The ideal candidate is a hands-on problem solver who can interpret requirements, manage day-to-day quality operations, and help drive compliance and continuous improvement across teams.

Key Responsibilities

Quality System Execution & Maintenance

• Support the maintenance and continuous improvement of the Quality Management System in accordance with ISO 13485 and 21 CFR 820.
• Assist in updating, revising, and controlling quality procedures, work instructions, and forms.
• Conduct and document internal audits; support external audits (ISO, FDA, Notified Body, suppliers).
• Monitor quality metrics and support trending, reporting, and corrective actions.
• Support CAPA investigations, ensuring timely documentation, root cause analysis, and effectiveness checks.
• Maintain and support the Document Control and Training systems.
• Collaborate with R&D and cross-functional teams to ensure design control deliverables (e.g., FMEAs, risk files, design verification/validation documentation) are completed and compliant.
• Support design transfer activities, ensuring quality requirements are met prior to release to manufacturing.
• Assist in maintaining the Risk Management File throughout the product lifecycle.
• Support the supplier management program, including supplier qualification, monitoring, and performance review.
• Coordinate supplier investigations, SCARs, and follow-up activities.
• Assist with incoming inspection processes and supplier-related non-conformances.

Manufacturing Quality

• Support equipment calibration and maintenance programs.
• Assist with non-conforming material investigations, disposition activities, and documentation.
• Review and maintain Device History Records (DHRs) and Device Master Records (DMRs).
• Other duties as assigned.

Qualifications

Required Education and Training

• Bachelor’s degree in Engineering, Life Sciences, or related technical field.
• 5–8 years of experience in medical device Quality Assurance or Quality Systems.
• Experience with ISO 13485, 21 CFR 820, and global medical device regulations.
• Prior experience supporting audits, CAPA, design controls, and supplier quality.
• 1–2 years of supervisory or team-lead experience preferred (but not required).

Skills & Requirements

• Ability to collaborate effectively across functions and levels.
• Strong analytical and problem-solving skills, including root cause analysis.
• Proficiency in electronic document and requirements management systems.
• Knowledge of 21 CFR part 820 and ISO 13485.
• Excellent written and verbal communication skills, including presentations to executives.
• Excellent complex problem-solving skills.
• Experience in a startup or early-stage medical device environment.
• Experience supporting FDA inspections or Notified Body audits.
• Ability to travel to suppliers on an as-needed basis – (25%).

What We Offer

• Competitive compensation and benefits package
• Opportunity to work on innovative medical technologies that improve patient outcomes
• Collaborative and mission-driven culture

Equal Opportunity Statement

StimCardio is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity or expression, national origin, age, marital status, disability, veteran status, or any other characteristic protected by law.

We’re always interested in connecting with talented professionals. If you don’t see a position that fits your background, please send your CV to [e-mail] and include a brief note describing the type of role you’re seeking.