Quality Assurance Manager

About the role

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.

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.

Responsibilities

• 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.

Requirements

• 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.

Skills

• 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