Document Control Specialist

OrthAlign, Inc., a Smart Technologies, growing medical device company, has an immediate opening for a Document Control Specialist. The Document Control Specialist is responsible for overseeing the document change control and training processes, and administrating the change process at OrthAlign to ensure it meets regulatory and internal requirements. This role maintains various controlled documents and administers the training program for internal employees. Document Control also creates and maintains Quality Management System profiles, facilitates periodic reviews for training plans and Quality documents, and supports QA during audits.

You will:

• Assign and track aging Document Assessments
• Review, route, and release change orders for compliance with OrthAlign requirements
• Suggest process improvements to ensure compliance and efficiency
• Support regulatory agency inspections and notified body inspections in concert with the Management Representative in retrieving requests
• Provide training and feedback to change order initiators, owners, and approvers
• Ensure retention and retrieval of official documents and records
• Assign new document and part number
• Monitor and respond to emails in document control email box
• Administer the training process to ensure timely and compliant training
• Ensure training plans are established for every employee at OA
• Update/assign training plans in eQMS
• Train new hires on eQMS software and training program
• Generate weekly training status report
• Generate weekly reports on Change Order Statuses
• Perform analysis for Quality Indices, Management Review, etc.

You need:

• Your AA/AS degree, 2+ years of experience, or without degree and 4 years, in Document Control in a regulated industry
• Experience using an electronic quality management system (e.g., QCBD, EtQ, etc.) and electronic document management system/PLM (e.g., Oracles Agile, Documentum, etc.)
• To demonstrate effective verbal, written and interpersonal communication skills
• ŸTo be self-motivated and with the ability to work as a collaborative team member as well as independently
• ŸUnderstanding of 21CFR820 and ISO 13485 quality system requirements
• ŸExperience using an electronic quality management system, preferred
• ŸStrong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint) and PDF software
• ŸTo be results-oriented with appropriate urgency
• ŸExcellent attention to detail, producing high quality output
• ŸFlexibility and strong organizational skills with ability to prioritize multiple tasks
• ŸAbility to apply sound judgment when making decisions and communicating with internal and external customers

We offer:

• Competitive compensation including bonus and equity
• Opportunities for career advancement
• Full benefits package
• An evolving, engaging culture and workplace
• Nominated by our employees as a Top Place to Work in Orange County!

It is an exciting time at OrthAlign - make your next career move with us!

Please note that we are unable to provide any type of sponsorship at this time.

No recruiters, please.