Quality Assurance Leader: FDA/ISO, Hybrid Dallas

Koya Medical, Inc.; Dallas (TX); Hybrid; USD 105,000 - 110,000; Full time

Job summary

Koya Medical, Inc. in Dallas, TX is seeking a Quality Assurance Manager to lead the QMS, ensure FDA 21 CFR Part 820 and ISO 13485 compliance, and drive continuous improvement across the organization.

You will manage document control, CAPA, audits, supplier qualification, training, and risk management with cross-functional teams to sustain a culture of quality and regulatory excellence. This full-time, hybrid role reports to the Director of Quality.

Qualifications

• Bachelor’s degree in Engineering, Quality Management, Life Sciences, or related field.
• 5+ years of experience in Quality Systems, Quality Assurance, or Regulatory Compliance in the medical device industry or FDA-regulated environment, with at least 2 years in a leadership role.
• Strong expertise in FDA 21 CFR Part 820, ISO 13485:2016, and ISO 14971 requirements.
• Experience in QMS management, CAPA, document control, internal audits, complaint handling and MDR reporting, nonconforming material, and risk management.
• Hands-on experience administering an electronic QMS or PLM platform (Arena preferred).
• Excellent organizational, analytical, and problem-solving skills.
• Strong leadership and communication skills with cross-functional experience.

Responsibilities

• Lead the implementation, maintenance, and improvement of the QMS for regulatory compliance and operational effectiveness.
• Oversee document control processes ensuring accuracy and regulatory compliance.
• Manage Device Master Records (DMR) and Design History Files (DHF) documentation.
• Ensure change control processes are followed and compliant.
• Establish and track quality KPIs to drive improvements.
• Oversee CAPA system including root cause analysis and timely closures.
• Prepare quality data for management review.
• Review/approve validation protocols and reports for production and quality system software.
• Develop and maintain procedures to comply with FDA/ISO standards.

Skills

Leadership

Regulatory knowledge

CAPA

QMS management

Internal audits

Document control

Risk management

Education

Bachelor’s degree in Engineering/Quality Management/Life Sciences

Tools

Arena PLM

NetSuite

Google Workspace

Microsoft Office Suite

Job description

Koya Medical, Inc. in Dallas, TX is seeking a Quality Assurance Manager to lead the QMS, ensure FDA 21 CFR Part 820 and ISO 13485 compliance, and drive continuous improvement across the organization.

You will manage document control, CAPA, audits, supplier qualification, training, and risk management with cross-functional teams to sustain a culture of quality and regulatory excellence. This full-time, hybrid role reports to the Director of Quality.