Control engineer h1.location_city

Specialist, Document Control

Irvine, CA Corporate Office Environment

Job Description Summary

Coordinates, implements, and maintains the company's Document/Change Control and Training Management systems. Follows established procedures and policies needed to meet the demands of document control in a regulated medical device company. Support company goals and objectives, policies and procedures, Quality System requirements, and all applicable regulations.

Job Responsibilities

• Processing of controlled documents and items approved via change control system including, but not limited to:
• Review change orders and non-change order type documents to ensure compliance to company document and change control procedures.
• Incorporation of document changes and release of all current and inactive controlled documents in hard copy and electronic formats.
• Verification of completion of DCO-related activities, such as material disposition and training, to ensure closure of DCO following completion of these activities.
• Creation and maintenance of Items, BOMs, and Routings in ERP system to support operations.
• Distribution of copies of the latest revisions of controlled documents to control locations.
• Destruction of copies of the outdated revisions of controlled copies, as required.
• Maintenance of controlled documents in such a manner as to prevent loss or damage, and to allow future access, including hard copy of electronic back-up files and/or fireproof file cabinets.
• Maintenance of index of current controlled documents.
• Provide training to Document / Change Control System and processes to internal customers, as required.
• Review Quality Records for adherence to Good Documentation Practices (GDP) and compliance to governing procedures, as applicable.
• File and maintain quality documents and records, including but not limited to DCO's, controlled document masters, test protocols and reports, Design History Files, Device History Records, Lab Notebooks, and other Quality Records. Ensure documents and records are retained per company procedures.
• Coordinate archiving of controlled documents and quality records to off-site storage.
• Monitor and track site personnel training compliance and file associated training records. Send reminders to employees for overdue training.
• Actively support and occasionally lead (as required) changes to Document and Change Control processes and documentation as required.
• Support QA in preparation of an internal and external audits/regulatory facility inspections.
• Perform other duties as assigned by supervisor.

Qualifications

Required Education and Experience:

• A high school degree is required. Minimum of 3-5 years' experience in Document Control within the medical devices, pharmaceutical or other regulated industry. Medical device is preferred.
• Understanding of 21CFR820 and ISO 13485 quality system requirements.
• Prior experience with ERP and electronic Document Control & Training Management systems.

Skills and Abilities Required for This Job:

• Takes initiative, self-starter, and the ability to conduct hands-on work with minimal supervision.
• Proficient with MS-Office applications Word, PowerPoint, Excel and PDF applications such as Adobe PDF.
• Work effectively and collaborate within cross-functional teams.
• High attention to detail.
• Ability to read and understand documents. Familiarity with bills of materials.
• Ability to file and organize records. Knowledge of document scanning and printing equipment; ability to utilize electronic files.
• Good oral and written communication skills.

Physical Requirements:

• Prolonged sitting