Job Summary: The primary purpose of this job is to perform all of the Quality System Document Control functions including the management of the Change Control Process, filing and archiving of records, and serve as administrator of the Document Control System to assure compliance to current standards and regulations.
Accountabilities and Responsibilities:
1. Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
2. Leads and maintains the Change Control Process. This includes the preparation of the change requests, insuring the appropriate functional reviews and sign-off, and maintaining the records of the changes. Posts changes to computerized or manual records, releases documents, and notifies affected departments.
3. Maintains an established data distribution system and expedites review, signature approval and release of documentation in a timely manner.
4. Analyzes and develops recommendations to improve current processes.
5. Responsible for managing SharePoint Quality documentation and maintaining the Change Control Database.
6. Confers with change originators to prepare documents and change requests. Works with document originators to resolve discrepancies in order to make required changes to the documentation.
7. Actively participates in external and internal audits.
8. Responsible for record retention process.
9. Participates in the creation of new processes to improve Quality System.
10. Manages and maintains active, obsolete, and computerized files which support the documentation system.
11. Performs other functions as required.
Minimum Education & Experience: Technical Associate's degree with 5-7 years experience in business or technical field OR Bachelor's degree with 2 years of experience in related field.
Specialized Knowledge: Previous experience in Engineering and Documentation Control Systems.
Special Skills: Ability to read and develop technical drawings/prints and solid technical writing skills.