Overview
Quality Assurance Lead Jobs in Fort Worth, TX at Memsel
Title: Quality Assurance Lead
Company: Memsel
Location: Fort Worth, TX
Head of Quality Assurance – Memsel
Fort Worth, TX | Full‑time | On‑site
($130k – $150k)
About Memsel
Memsel develops scientific technologies that advance public health and safety. Our team works across R&D, quality, regulatory, and operations to bring reliable, impactful biotechnology products to market. Join a mission‑driven company innovating at the intersection of biotechnology and medical devices.
About the Role
We’re seeking a Head of Quality Assurance to lead and continuously improve our ISO 13485–compliant Quality Management System. You will ensure compliance with 21 CFR 820, guide the organization through audits and inspections, and oversee supplier quality and cybersecurity requirements related to CMMC Level 2. This is a hands‑on leadership role in a fast‑growing, regulated environment.
What You'll Do
• Maintain and oversee Memsel’s QMS (ISO 13485 compliant)
• Ensure compliance with 21 CFR 820 across development, testing, and manufacturing
• Lead internal audits and serve as the primary contact during FDA, ISO, and customer audits
• Manage nonconformance, investigations, root‑cause analysis, CAPA, and verification
• Support risk management activities aligned with ISO 14971
• Collaborate with R&D, engineering, manufacturing, and regulatory teams
• Develop and update SOPs, work instructions, and quality procedures
• Oversee supplier qualification, performance tracking, and corrective actions
• Maintain documentation and compliance for CMMC Level 2 cybersecurity requirements
• Provide QMS and compliance training to internal teams
• Drive continuous improvement using metrics and best practices
• Prepare quality reports and management review documentation
What You Bring
Required:
• Bachelor’s degree in engineering, life sciences, quality, or related field
• 3+ years of QA or QMS experience in medical devices, biotech, or regulated industries
• Strong knowledge of ISO 13485 & 21 CFR 820
• Experience with FDA or ISO 13485 audits
• Proficiency in CAPA, document control, validation, and risk management
• Familiarity with CMMC Level 2 compliance
• Excellent communication and organizational skills
Preferred:
• ASQ CQE, CQA, or similar certification
• Experience in lab‑based device development or testing
• Knowledge of ISO 14971
• Experience with eQMS or digital quality systems
• Lean Six Sigma or continuous‑improvement training
Benefits
• Medical, dental & vision insurance
• Life insurance
• Short‑ and long‑term disability
• Paid vacation and sick leave
• Company‑observed holidays
• Additional employee benefits available
Additional Information
• Must be authorized to work in the U.S.
• Employment contingent upon background check
• Memsel is an Equal Opportunity Employer committed to diversity, inclusion, and reasonable accommodations.
