Senior Quality Systems Specialist

1 week ago


Carlsbad, United States Mosaic People Solutions Full time

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 companys 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

Bachelors 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.



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