A leading medical device company that aims to improve cancer surgery is seeking an experienced Document Control Specialist to join the team!This Jobot Job is hosted by: Amber BasingerAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $60,000 - $85,000 per yearA bit about us:A fast-paced start-up that is focused on innovative cancer surgery solutions!Why join us?Hybrid schedule (onsite 2-3 days per week)100% employer covered health, dental, vision, disability (long & short-term), and life insurance plansComplimentary on-site garage parkingDog-friendly office spaceStay-active space with table tennis, foosball, and video gamesJob DetailsResponsibilities:
- Administrate Arena quality software system and document control process, including acting as a project manager to lead minor change control projects.
- Coordinate and maintain controlled documentation both physically and electronically according to approved procedures.
- Assist with file migration to storage, both physically and electronically, as applicable.
- Coordinate and execute the migration of legacy documentation stored outside of the eQMS into Arena.
- Ensure all documents are current, properly identified, and maintained per applicable standards and regulations.
- Aid in investigation and improvement initiatives for quality processes.
- Review records and documents for completeness and compliance with FDA Quality System Requirements and ISO requirements.
- Assist in companywide training on general quality principles and specific procedural requirements.
- Other activities as assigned by supervision including cross-training in other areas of quality and regulatory as applicable.
- Teach and lead others in developing quality skills.
- Initiate and drive quality system process improvement.
- Assist, coordinate and participate in quality system audits and regulatory inspections.
- Conduct process quality measurements/evaluations.
- Assists in monitoring, analyzing, and reporting trends in key quality metrics.
- Ensures established department timelines are attained.
- Minimum of a bachelor's degree in a life sciences, healthcare, or technology discipline (Preferred).
- Knowledge & Skills: