What are the responsibilities and job description for the Document Control Specialist position at Nalu Medical, Inc.?
The Document Control Specialist is a quality focused individual who ensures documentation and record keeping processes conform to Nalu Medical QMS, ISO 13485, FDA 21CFR820, and other regulatory requirements. The individual will oversee the day-to-day document control, device history record, and record management activities.
Responsibilities:
- Performs document control functions, including tracking, processing, review, distribution, release and archiving of documents.
- Coordinates the revision, review, approval and obsoleting of controlled QMS documents.
- Responsible for reviewing and approving Device History Records for product release.
- Organizes and ensures accurate and reliable filing systems for all QMS documents.
- Maintains change control and deviation processes for work instructions, specifications, and QMS documents.
- Actively participates in internal audits, FDA inspections, ISO certification audits and other activities as necessary.
Requirements:
- 3 -5 years of experience in document control in an ISO 13485 Quality Management System, medical device industry experience preferred.
- High school diploma or general education degree (GED),
- Associate's and/or Bachelor's degree in related field preferred.
- Well-organized and proficient at reviewing and editing documentation.
- Proficient in MS office applications such as Word, Excel, PowerPoint and Adobe Acrobat.
- Attention to detail while executing multiple tasks.
- Self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines.
- Strong writing skills (technical writing, customer communication).
- Exhibit a quality mindset and a willingness to develop yourself and others.
- Excellent oral and written communication skills with an emphasis on listening to others.
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