Position: Document Control Analyst
Pay: $50-58/hr
Location: ONSITE in Sunnyvale, CA
Type: W2
Overview:
The primary focus of this position is managing documentation and records within a regulated environment, specifically in the medical device industry under ISO 13485 standards. This role requires strong attention to detail, regulatory knowledge, and document management expertise. If you're considering applying, having experience in medical device documentation and compliance would be a major advantage.
Key Responsibilities:
- Overseeing Quality Management System (QMS) documentation throughout the product lifecycle.
- Creating and releasing documents for new product introduction, clinical trials, and FDA submissions.
- Ensuring document integrity, accessibility, version control, and compliance with regulatory requirements.
- Collaborating with Operations, Supply Chain, and Engineering to maintain compliance with medical device standards.
- Supporting audits, accreditation submissions, and periodic document reviews.
- Managing complex projects and priorities related to documentation.
- Assisting with the implementation of new electronic Quality Management Systems (eQMS).
Must haves:
Document control experience, Familiarity with FDA and ISO 13485, & CFR part 11 experience
Nice to haves:
Familiarity with team center, Basic knowledge of PLM processes, Experience working in a regulated med device environment
Required Qualifications:
- 5+ years of experience in a high-tech, fast-paced consumer electronics environment managing medical device documentation.
- Experience with Teamcenter or similar PLM/Document Management systems.
- Familiarity with Google Suite and ISO 13485 standards.
Day to day:
Support Med Devices Documentation, SOPs, History files and records to support FDA Compliance, and ISO 13484 Compliance, quality management systems documents (SOP's)
Requirements:
5+ years of related experience in a high tech, fast paced, consumer electronics environment managing medical device Quality Management System documentation and resulting records Experience with Teamcenter or related PLM/Document Management systems Experience working on a regulated Medical Device environment Familiarity with Google Suite Familiarity with ISO 13485