Quality Specialist

Huxley Medical is a leading innovator in the medical device industry, committed to improving patient outcomes through high-quality, safe, and effective products. We are currently seeking a Quality Specialist to join our team and help drive compliance, continuous improvement, and quality excellence across our operations.

The Quality Specialist will play a critical role in ensuring that our products and processes comply with regulatory standards, including FDA 21 CFR Part 820 and ISO 13485. This position monitors QA systems and compliance activities related to production and post-market surveillance. Ensures adherence to regulatory and company quality system requirements. Supports inspection readiness and document control functions. Acts as the subject matter expert (SME) for the quality management system (QMS).

Leads initiatives to improve system effectiveness, including document control, quality inspection, training, change control, and CAPA processes.

• Assist in monitoring and trending quality metrics (Complaints, NCRs, CAPAs, Supplier, etc.)
• Support in audit readiness and participate in internal and external audits (i.e. FDA audits)
• Train internal teams on quality and compliance procedures
• Maintain and improve QMS in compliance with ISO 13485 and FDA QSR
• Maintain the Document Control and Change Control systems
• Maintain the Training program
• Assist in the maintenance of equipment control records, cleaning log records, and supplier records
• Perform Quality Inspection processes
• Track investigations to ensure timely completion (NCRs, CAPAs, Deviations, Complaints, SCARs); manage open corrective actions/open reports, file completed records, and etc.
• Support in the authoring, review, and tracking of submitted investigations and completed assigned corrective actions
• Ensure compliance with internal procedures and regulatory requirements (21 CFR and ISO 13485)
• Partner with R&D, Manufacturing and other teams to ensure quality integration

• Bachelor’s degree in Life Sciences, Engineering, or a related technical field
• 3+ years of experience in Quality Assurance within the medical device industry or related field
• Knowledge of FDA QSR, ISO 13485, and ISO 14971
• Excellent communication and cross‑functional collaboration skills

• Experience with Class II or III medical devices
• Experience with risk management, root cause analysis (e.g., 5 Whys, Fishbone), and quality management system

Mid‑Senior level

Full‑time

Quality Assurance