Quality Assurance Manager

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.

We’re seeking a Quality Assurance Manager 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.

• 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

• 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

• Knowledge of ISO 14971
• Experience with eQMS or digital quality systems
• Paid vacation and sick leave
• Additional employee benefits available

• 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.