Quality Specialist – ISO 13485 & FDA QSR

About the role

We are seeking a highly organized Quality Specialist to help XDemics establish and maintain an ISO 13485 and FDA QSR compliant quality management system for our cell culture products classified as Class I medical devices. The role is fast‑paced, startup‑oriented, and requires ownership, proactive problem‑solving, and strong attention to detail.

Key responsibilities

• Support development, implementation, and maintenance of quality systems compliant with ISO 13485, FDA QSR, and related regulations.
• Lead root‑cause analysis and CAPA for product and process non‑conformances.
• Handle non‑conformances, perform incoming inspections, and conduct component qualification studies.
• Support design control activities, including risk management (ISO 14971), verification, validation, and design reviews.
• Conduct internal and supplier audits to ensure compliance with quality standards.
• Collaborate with R&D, Manufacturing, and Regulatory Affairs to embed quality into product development and manufacturing.
• Create, review, and approve quality documentation such as protocols, reports, SOPs, and work instructions.
• Execute installation qualifications (IQ) and operational qualifications (OQ) and write/execute process validations.
• Maintain controlled manufacturing areas, monitor quality metrics, and drive continuous‑improvement initiatives.
• Participate in regulatory inspections and third‑party audits.
• Manage material handling activities, including receipt, inspection, inventory organization, and safe scrap handling.
• Collaborate with EH&S to maintain a safe workplace.

Required profile

• Highly organized with strong attention to detail.
• Excellent communication and collaboration skills.
• Ability to manage multiple priorities in a fast‑moving environment.
• Professionalism, discretion, and accountability.
• Experience in quality systems for medical devices or related regulated industries.

Required skills

• ISO 13485
• FDA QSR
• ISO 14971 (risk management)
• CAPA management
• Root cause analysis
• Design control
• Internal and supplier audits
• SOP development and document control
• Installation qualification (IQ) and operational qualification (OQ)
• Process validation
• Incoming inspection
• Material handling
• Collaboration with EH&S