Senior Documentation Specialist

Senior Documentation Specialist Ramsey, MN 55303, USA Req #2029 Thursday, April 4, 2024

Join The Hoya Vision Care Team

For over 60 years, HOYA Vision Care has been a passionate leader in optical technology innovation. As a manufacturer of high quality, high performing eyeglass lenses, we continuously aim to bring the best possible vision care solutions to eye care professionals.

We are currently hiring a Sr. Documentation Specialist

What's in it for you?

• Health/Dental/Vision/Disability Insurance
• Tuition Reimbursement
• 401K plans
• PTO and Paid Holidays
• And more

What you'll do:

• Lead the development of the Document Control System
• Manage (arrange, file and maintain) documents and records (DHF, DMR, Quality) and ensure their quality, accuracy and integrity
• Maintain the document change management system
• Create, modify and process change requests
• Issue control numbers (i.e. document, equipment, test)
• Format and edit documents to ensure accuracy to internal requirements (i.e. SOP, Work Instruction)
• Provide ongoing training for document control system improvements
• Serve as the primary representative for audits of the Document Control System
• Report on Document Control System performance

Qualifications:

• Document control experience in a regulatory environment: 5+ years with an Associate degree / 2+ years with a 4-year degree
• Working knowledge of the documentation and records related clauses of ISO 13485 and FDA is strongly preferred

• Experience in building document control systems is preferred
• Experience in a medical device start-up environment is a plus
• Experience as a technical writer is a plus

Other details

• Job Family Production
• Pay Type Salary

• Ramsey, MN 55303, USA

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