Document Control Specialist at Veran Medical
St. Louis, MO, US
- Managing company documents while also ensuring their accuracy, quality and integrity. Store, manage and track company documents across functions and across additional sites.
- Control the release and retrieval of quality system documents. Receive and process requests for changes and updates to documents from various functions/employees and maintain these requests.
- Control and manage the companies master list of external standards and documents and ensure updates/modifications are tracked and updated.
- Scan, image, organize and maintain documents, adhering to the company’s document lifecycle procedures and archive inactive/obsolete records in accordance with the records retention schedule.
- Ensure functional groups adhere to company’s record retention policies, safeguard information and retrieve data more effectively.
- Collect and maintain files of the latest revision level documentation necessary to define product configuration/specification and control manufacturing processes.
- Timely distribution of latest revision level documentation to all appropriate users and ensure that obsolete documentation is removed from distribution.
- Maintain a database of all filed documentation that ensures fast retrieval of documents.
- Assist functional managers in developing and maintaining documents such as meeting minutes, drawings, specifications, approvals and related items.
- Assist with file migrations and audits and perform administrative tasks as needed.
- Perform clerical typing duties to generate documents as necessary.
- Bachelor’s degree preferred OR demonstrated equivalent experience
- 1 to 3 years of medical device document control and records related experience preferred
- Certification as an ASQ Technician preferred, but not mandatory
- Knowledge of ISO 13485:2016, FDA Quality System Regulation, MDR knowledge preferred
- Good record-keeping and attention to detail
- Strong communication skills, with the ability to interact with all organizational levels
- Ability to read, write and speak English
- Organizational skills, detail oriented, trustworthy
- Thoroughness, self-directed, acts independently
- Able to read and interpret documents and standards