Overview
Quality Assurance Specialist II Jobs in Dallas, TX at Koya Medical, Inc.
Title: Quality Assurance Specialist II
Company: Koya Medical, Inc.
Location: Dallas, TX
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.
About Koya Medical
Koya Medical, a privately held company founded in 2018, is a transformative healthcare company developing breakthrough treatments for venous diseases and lymphedema to enable joint contractions, patient mobility, and personalized care that is unavailable with traditional compression therapy. 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.
Description
Job Summary
We are looking for an enthusiastic and detail-oriented Quality Assurance Specialist II to join our small but mighty team. In this role, you will Independently support and manage key Quality System processes, including complaint handling, nonconformance investigations, CAPA documentation, internal audits, and quality metrics trending. Ensures compliance with ISO 13485 and FDA QMSR requirements while collaborating cross-functionally to resolve quality issues and support regulatory readiness. This position will report to the Quality Assurance Manager. The role is full time, exempt and will work on-site (based out of our Dallas location).
Essential Duties And Responsibilities
The essential functions include, but are not limited to the following:
- Independently manage complaint handling, including investigation coordination and documentation review.
- Lead nonconformance investigations and support root cause analysis activities.
- Author and maintain CAPA records, ensuring compliance with procedural and regulatory requirements.
- Conduct internal audits and prepare audit reports.
- Perform risk-based evaluation of quality issues and recommend corrective actions.
- Review and approve controlled documents per delegated authority.
- Monitor quality metrics and prepare trending reports.
- Support supplier qualification activities and supplier performance monitoring.
- Participate in regulatory inspection readiness activities.
- Provide training to cross-functional personnel on QMS procedures.
Minimum Qualifications Education, Experience And Training
- Bachelor’s degree in a scientific, engineering, or related discipline (or equivalent combination of education and experience).
- 2–5 years of experience in a regulated industry (medical device preferred).
- Working knowledge of ISO 13485 and FDA QMSR (21 CFR 820).
- Experience with complaint handling, nonconformance investigations, and CAPA processes.
- Experience conducting or supporting internal audits.
- Strong analytical and root cause analysis skills.
- Excellent interpersonal skills and a spirit of teamwork
Core Competencies
Continuous Improvement, Problem Solving, Service Focus, Collaboration & Team, Communication, Change Agility, Mission & Vision Focus
Tools and Technology
Microsoft Office Suite, Google Suite, Arena PLM, Adobe
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. 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.
Salary
$64,000 – $73,000 per year
