Document Control Specialist
Medical Device
$40-$50K
We are working with a start-up looking to expand their Quality team and supporting a search for a Quality Engineer. This position is full-time onsite with a company who has recently secured significant funding and has large growth plans.
Duties & Responsibilities:
- Maintain documentation per ISO 13485, FDA 21 CFR 820/Part 11, and EU MDR.
- Support internal/external audits and manage documentation requests.
- Manage and organize Quality System files (DHR, DMR, DHF).
- Coordinate document change orders (DCO) and Risk Management documents.
- Investigate and address corrective actions for Document Control.
- Interface with FDA and ISO auditors regarding documentation.
- Conduct internal audits as needed.
Position Requirements:
- Strong multitasking, self-motivation, and organization skills.
- Proficient in 21 CFR 820, ISO 13485, and medical device regulations.
- 1-2 years of experience in a regulated industry preferred.
- Advanced Microsoft Office skills.
- Excellent communication and detail-oriented data entry.
- Ability to work independently and in teams.
No C2C / Sponsorship
Onsite Role