Koya is always looking for curious and passionate individuals who want to join a fast-paced team for a career in transforming venous and lymphatic care through innovative people-centric technologies that improve lives and empower self-care. Koya values integrity, humility, hard-work, camaraderie, and fun. We offer a base + bonus compensation package, and a competitive benefits program.

Join Our Team

Koya is always looking for curious and passionate individuals who want to join a fast-paced team for a career in transforming venous and lymphatic care through innovative people-centric technologies that improve lives and empower self-care. Koya values integrity, humility, hard-work, camaraderie, and fun.

We offer a base + bonus compensation package, and a competitive benefits program.

Job Summary

The Quality Assurance Manager is responsible for the oversight, implementation, and continuous improvement of the Quality Management System (QMS), ensuring compliance with FDA 21 CFR Part 820 (Quality Management System Regulation), ISO 13485:2016, and other applicable regulatory requirements. This role drives quality system initiatives, manages document control and training, oversees post-market surveillance activities, and ensures effective CAPA, audit, and risk management processes. The Quality Assurance Manager will collaborate with cross-functional teams to maintain a culture of quality and regulatory excellence.

This position will report to the Director of Quality. The role is full time, exempt and will work in our Dallas, TX location.

Essential Duties and Responsibilities

The essential functions include, but are not limited to the following:

Quality Management System (QMS) Oversight

· Lead the implementation, maintenance, and improvement of the QMS to ensure regulatory compliance and operational effectiveness.

· Oversee document control processes, ensuring accuracy, accessibility, and compliance with regulatory requirements.

· Manage and maintain Device Master Records (DMR), Design History Files (DHF), and other regulatory documentation.

· Ensure that change control processes are followed, properly documented, and compliant with internal and external requirements.

· Establish and track quality system performance metrics (KPIs) to drive continuous improvement initiatives.

· Oversee the CAPA system, ensuring effective root cause analysis, implementation of corrective actions, and timely closure of quality issues.

· Prepare and present quality system data for management review.

· Review and approve process, equipment, and software validation protocols and reports, including software used in production or as part of the quality system.

Regulatory Compliance & Audit Management

· Develop and maintain quality system procedures and policies to comply with FDA, ISO 13485, and other applicable regulatory standards.

· Serve as the primary lead for internal audits, ensuring timely execution and follow-up on corrective actions.

· Prepare for and lead external audits and regulatory inspections.

· Monitor regulatory changes and implement necessary updates to maintain ongoing compliance.

Complaint Handling & Post-Market Surveillance

· Own the complaint handling process end to end, including intake, investigation, documentation, and timely closure.

· Make and document medical device reporting decisions and submit MDRs to FDA per 21 CFR Part 803.

· Trend complaint and post-market data and feed the results into CAPA, risk management, and management review.

· Support health hazard evaluations, field actions, and corrections and removals reporting per 21 CFR Part 806.

Risk Management & Supplier Quality

· Implement and oversee risk management processes (ISO 14971) to ensure proactive identification and mitigation of quality risks.

· Collaborate with quality engineers to manage supplier qualification, monitoring, and audit processes, ensuring suppliers comply with company and regulatory requirements.

· Collaborate with procurement and engineering teams to assess and mitigate supplier-related quality risks.

Training & Continuous Improvement

· Develop and maintain quality training programs, ensuring employees understand and adhere to quality system requirements.

· Maintain training records and competency matrices, ensuring regulatory compliance.

· Lead continuous improvement initiatives, leveraging Lean, Six Sigma, and other process optimization tools to enhance QMS efficiency.

· Drive a culture of quality excellence, promoting cross-functional collaboration on quality initiatives.

Minimum Qualifications

· Bachelor’s degree in Engineering, Quality Management, Life Sciences, or a related field, or an equivalent combination of education and experience in a Quality Management role.

· 5+ years of experience in Quality Systems, Quality Assurance, or Regulatory Compliance in the medical device industry or another FDA-regulated manufacturing 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 experience working cross-functionally.

Preferred Qualifications

· Certified Quality Auditor (CQA), Six Sigma, or ASQ certification.

· Expertise in regulatory submissions, external audits, and notified body interactions.

· Experience supporting an ERP implementation or migration in a regulated manufacturing environment.

Core Competencies

Continuous Improvement, Problem Solving, Collaboration & Team, Change Agility

Supervisory Responsibilities

Setting targets for performance in ways that align with Koya’s corporate goals and vision. Organizing workflow and ensuring that employees understand their work and priorities. Monitoring employee productivity and providing constructive feedback and coaching. Hiring, training and developing team members. Assessing employee performance and achievement of goals. Leading, motivating and empowering staff.

Tools and Technology

Arena PLM, NetSuite, Google Workspace, Microsoft Office Suite

Physical Functions and Work Environment

The physical functions described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

Primarily office-based with occasional interaction on the production floor.

Ability to travel for supplier audits or regulatory engagements as needed.

While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers; handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.

Note

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any Koya manager authorized to provide instruction or assign work. Duties, responsibilities, and activities may change at any time with or without notice.

All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with

disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.

Koya Medical, Inc. is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.