Quality Engineering Document Control Specialist-Newark, DE
Siemens Healthineers
•$81,780 - $112,453•Onsite
About The Position
Join our team and help ensure the quality, accuracy, and compliance of critical documentation that supports products impacting lives. We’re seeking a detail-oriented Document Control Specialist to drive excellence in our GMP document and records management processes.
Requirements
- Bachelor’s degree in related field.
- 2+ years of document control or quality systems experience in a regulated industry.
- Strong understanding of GMP documentation processes
- Excellent writing, proofreading, and organizational skills
- Ability to manage multiple priorities and collaborate cross-functionally
- Proficiency in MS Office and Adobe
- Must be able to work with controlled technology in accordance with US export control law.
Nice To Haves
- Manufacturing experience preferred.
- eQMS/SAP experience is a plus
Responsibilities
- Manage the full document lifecycle (approval, versioning, distribution, archiving, obsolescence)
- Maintain QMS documentation including SOPs, Work Instructions, and GMP records
- Ensure compliance with FDA (21 CFR Part 820), ISO 13485, MDR, and IVDR
- Support and troubleshoot the electronic document management system (eDMS)
- Collaborate cross-functionally to create and improve documentation
- Provide training and guidance on document control processes
- Support audits, CAPA activities, and continuous improvement
- Track and analyze quality metrics
Benefits
- medical insurance
- dental insurance
- vision insurance
- 401(k) retirement plan
- life insurance
- long-term and short-term disability insurance
- paid parking/public transportation
- paid time off
- paid sick and safe time
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
