Quality Assurance Manager
About The Position
The Quality Assurance Manager oversees, implements, and continuously improves Koya’s Quality Management System (QMS), ensuring compliance with FDA 21 CFR Part 820, ISO 13485:2016, and other applicable regulatory requirements. The role leads quality-system initiatives; manages document control and training; oversees post-market surveillance; and ensures effective CAPA, audit, and risk-management processes. The manager works with cross-functional teams to support a culture of quality and regulatory excellence and reports to the Director of Quality. This is a full-time, exempt position based in Dallas, Texas. The position leads QMS implementation and maintenance, document control and regulatory records, change control, quality metrics, CAPA, management-review reporting, and review and approval of validation protocols and reports. It develops compliant procedures and policies, leads internal and external audits and regulatory inspections, and monitors regulatory changes. It owns complaint handling and MDR decisions and submissions, trends post-market data, and supports health hazard evaluations and field actions. The role also oversees risk-management processes, collaborates on supplier qualification and quality risks, maintains employee training programs and records, and leads continuous-improvement initiatives using Lean, Six Sigma, and other process-optimization tools. The role includes supervisory duties such as setting performance targets, organizing workflow, coaching and developing employees, hiring, assessing performance, and motivating staff. The work is primarily office-based, with occasional production-floor interaction and travel as needed for supplier audits or regulatory engagements.
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.
- At least 5 years of experience in Quality Systems, Quality Assurance, or Regulatory Compliance in the medical-device industry or another FDA-regulated manufacturing environment.
- At least 2 years of experience 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.
- Excellent organizational, analytical, and problem-solving skills.
- Strong leadership and communication skills, including experience working cross-functionally.
Nice To Haves
- 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.
- Experience with Arena, which is preferred.
Responsibilities
- Lead implementation, maintenance, and improvement of the QMS to ensure regulatory compliance and operational effectiveness.
- Oversee document control and maintain Device Master Records, Design History Files, and other regulatory documentation.
- Ensure change-control processes are followed, documented, and compliant with applicable requirements.
- Establish and track quality-system performance metrics and present quality data for management review.
- Oversee CAPA, including root-cause analysis, corrective-action implementation, and timely closure of quality issues.
- Review and approve process, equipment, and software validation protocols and reports.
- Develop and maintain quality-system procedures and policies aligned with FDA, ISO 13485, and other applicable standards.
- Lead internal audits, external audits, and regulatory inspections, and ensure corrective-action follow-up.
- Monitor regulatory changes and implement updates to maintain compliance.
- Manage complaint handling from intake through investigation, documentation, and closure.
- Make and document medical-device reporting decisions and submit MDRs to FDA under 21 CFR Part 803.
- Trend complaint and post-market data and incorporate findings into CAPA, risk management, and management review.
- Support health hazard evaluations, field actions, and corrections and removals reporting under 21 CFR Part 806.
- Implement and oversee risk-management processes in accordance with ISO 14971.
- Collaborate with quality engineers, procurement, and engineering on supplier qualification, monitoring, audits, and mitigation of supplier-related quality risks.
- Develop and maintain quality training programs, training records, and competency matrices.
- Lead continuous-improvement initiatives using Lean, Six Sigma, and other process-optimization tools.
- Promote quality excellence and cross-functional collaboration.
- Set employee performance targets, organize workflow, coach and develop team members, hire, assess performance, and lead and motivate staff.
- Travel as needed for supplier audits or regulatory engagements.
Benefits
- Base plus bonus compensation package.
- Competitive benefits program.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
