Maintains document control and training systems in compliance with company procedures, medical device quality regulations, and external standards. Administers databases, supports employees, generates management and training reports, addresses audit-related quality gaps, coordinates group training, and collaborates with project managers to maintain Design History Files. May also support production, product development, and quality activities, including inspections and complaint-related work.
Company Description
About Trident:
Trident Consulting is an award-winning IT/engineering staffing company founded in 2005 and headquartered in San Ramon, CA. We specialize in placing high-quality vetted technology
Some of our recent awards include:
2022, 2021, 2020 Inc. 5000 fastest-growing private companies in America
2022, 2021 SF Business Times 100 fastest-growing private companies in Bay Area
Trident Consulting is seeking a "Document Control Coordinator" for one of our clients in "San Clemente, CA" A global leader in business and technology services.
Role: Document Control Coordinator
Location: San Clemente, CA
Type: Contract – Onsite
Pay: $20 - $22/hr on W2(Inclusive all)
Description
- This position is responsible for ensuring the document control and training systems are maintained and functioning in compliance with Clients procedures and external standards and regulations.
- In addition to QA responsibilities, there will be other activities required that support Production and Product Development as needed.
Document Control
- Administering the approved Document Control database system.
- Provide support to all personnel for document control
- Creating reports in the approved system for Management Review, Trending requests, etc.
- Maintaining the document control and training modules within the approved system
- Addressing quality system gaps within the document control system stemming from audits.
Training
- Administering the approved Training database.
- Provide support to all personnel for training
- Monitor the status of the training process
- Provide reports on the status of training
- Coordinate group training when needed Design History Files
- Working with project managers on compiling and maintaining the DHFs.
Required
- Experience requires 0-2 years of related experience Knowledge, Skills, and Abilities
- Must have excellent documentation skills
- Attention to detail and accuracy a must
- Medical device experience and working knowledge of QSR
- Medical device complaint experience preferred
- Experience working in a clean room and/or performing in-process assembly and manufacturing verification inspections desirable
- Team player, good written/oral communicator
- Able to thrive in a small, entrepreneurial environment
- Must be organized and able to coordinate activities with internal departments and outside vendors
Education: Bachelor’s degree, preferably in a science
Additional InformationAll your information will be kept confidential according to EEO guidelines.
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