Clinical QA Specialist

About the role

We are seeking a Clinical QA Specialist to support our Quality Management System (QMS) for clinical trial activities. This remote position focuses on ensuring regulatory compliance and quality excellence for proprietary medical device software.

Key responsibilities

• Plan, conduct, and document audit activities.
• Manage quality issues, complaints, non‑conformities and drive Corrective and Preventive Actions (CAPA).
• Qualify vendors and suppliers.
• Participate in quality management reviews and regulatory compliance reviews of documentation.
• Perform periodic reviews of controlled documents and internal file assessments.
• Maintain document control, including quality record upkeep.
• Support personnel training documentation and training record maintenance.
• Administer and maintain the company’s electronic QMS (eQMS).
• Contribute to the development, review, and revision of procedures aligned with the QMS.
• Assist with regulatory submissions related to medical device software.
• Organize QA‑related meetings, prepare agendas, minutes, and track action items.
• Provide cross‑departmental QA and regulatory compliance guidance.
• Report quality metrics to departmental leads or officers for management review.
• Perform additional departmental tasks as required.

Required profile

• Undergraduate degree with at least 3 years of quality‑related experience, or an equivalent education‑experience mix.
• Experience in the medical device, pharmaceutical, or biotech clinical research industry.
• Working knowledge of regulations, standards, and guidelines governing clinical trial quality.
• Experience with regulatory submissions for medical devices (preferred).
• Excellent written and oral communication, strong attention to detail, and solid organizational skills.
• Ability to manage multiple deadlines and collaborate with various departmental stakeholders.

Required skills

• eQMS (electronic Quality Management System) knowledge.