Our client, a well-funded startup in the medical device industry, is seeking a talented Senior Quality Systems Specialist to join their team in Carlsbad, CA. This dynamic company is dedicated to revolutionizing healthcare through cutting-edge technologies. The Senior Quality Systems Specialist ensures the development and maintenance of Quality Management System (QMS) processes for compliance and effectiveness.

Key Responsibilities

• Manage and support QMS processes, ensuring compliance with domestic and international regulations.

• Oversee all aspects of Document Control and Change Control processes.

• Maintain controlled documents (both paper and electronic) in line with the quality management system.

• Review and categorize incoming documents for accurate filing and record-keeping.

• Supervise the scanning and uploading of documents to the document management system.

• Oversee the entire lifecycle of QMS documents, from creation to archival.

• Edit and prepare incoming documents and change orders for distribution or routing.

• Develop and maintain efficient document filing and organizing systems.

• Ensure the organization and security of both paper and electronic documents.

• Maintain regulatory technical files, design dossiers, design history files, device master records, and other technical documentation.

• Track QMS logs and metrics to monitor process effectiveness.

• Present QMS trending data to management during reviews and meetings.

• Manage the employee training program, maintaining training records, job descriptions, and compliance with QMS requirements.

• Communicate the quality policy within the organization to ensure employee understanding.

• Support internal and external audits in line with company’s audit procedures.

• Collaborate with R&D, Operations, and QA/RA departments on design control, production, CAPA/NMR, and regulatory submission processes.

• Perform other duties as needed.

Qualifications

• Bachelor’s degree or equivalent.

• 2-7 years of experience in medical device quality management systems and/or document control.

• Strong attention to detail.

• Excellent written and oral communication skills.

• Ability to manage resources and time efficiently.