Remx is currently hiring several Document Control Specialists for a top Medical Device Manufacturing company in San Diego.
Must have medical device / FDA background
Salary is DOE
DC Specialist will perform the following duties:
- Reviews and analyzes proposed changes to identify deliverable, supporting data and approval requirements
- Facilitates the Change Control Process in the Change Control system
- Audits, receives, files, and maintains centralized documentation archiving system of controlled quality system documents
- Receives, classifies, files, audits, tracks and maintains centralized documentation archiving system of controlled Quality System documents according to established procedures.
- Help in the preparation of the legacy documents for migration into the electronic document control system
- Commitment to the development, implementation, and effectiveness of company Quality Management system (QMS) per ISO, FDA, and other regulatory agencies
- 3 plus years of Document Control experience in FDA environment
- Must have medical device manufacturing background
- Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR
- Experience in Change Orders and Change Control Systems: SAP, Agile, others.
- High School Diploma / GED
Forward resumes for interview consideration. Company is moving quickly on qualified candidates.