Join our cardiovascular electrophysiology client’s rapidly growing team and help as they embark on an exciting phase of their development! The company is eager to find a talented Document Control Specialist to manage and maintain quality-related documentation. This position ensures regulatory compliance, oversees version control, and supports communication and training on document changes. The Document Control Specialist also assists with internal and external audits, utilizes Electronic Document Management Systems, and works closely with other departments to maintain adherence to quality management practices.
Qualifications of the Document Control Specialist:
High school diploma or equivalent.
7+ years of experience in a regulated industry, preferably biotech or medical device.
Knowledge of document control processes, quality assurance, and ISO 13485 Quality Management Systems.
Understanding of medical device regulations and good manufacturing practices.
Strong attention to detail and commitment to continuous improvement.
Responsibilities of the Document Control Specialist:
Manage the Document Change Order (DCO) Process for the release, approval, distribution, maintenance, retrieval, and storage of quality system documents and records in accordance with Standard Operating Procedures.
Support the Change Control Board (CCB) to process DCOs, implement changes, complete product disposition, and oversee timely completion of DCO activities.
Maintain and support compliance activities related to the Quality Management System (QMS) in line with international and domestic regulations.
Manage the employee training program and maintain the training matrix by collaborating with hiring managers to ensure current training records, job descriptions, and employee files are in compliance.
Maintain control of electronic and hard copies of documents, including SOPs, product specifications, inspection procedures, clinical documentation, process validation, and more.
Update and maintain the Master Document List and Document Change Control Logs to ensure accurate record-keeping.
Support and maintain Design History Files, Regulatory Technical files, Device Master Records, and other required documentation.
Assist with internal audits in compliance with internal audit procedures.
Maintain quality system databases to provide quality metrics and summaries for management review and other meetings as required.
Assist during external audits by regulatory bodies (e.g., FDA, Notified Body, California State Department of Public Health).
Support product development projects to ensure compliance with regulatory requirements.
Provide assistance during regulatory submissions and communication with agencies such as the FDA and Notified Body.
