Quality Document System Management Specialist
Job in
Sparks, Baltimore County, Maryland, USA
Listed on 2026-06-03
Listing for:
millenniumsoft
Full Time
position Listed on 2026-06-03
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst, Regulatory Compliance Specialist, Quality Engineering
Job Description & How to Apply Below
Location: Sparks
Roles & Responsibilities
- Respond to customer and internal requests related to quality and regulatory documentation
- Provide support during on-site audits and inspections
- Maintain and update quality system procedures and records
- Investigate and analyze quality-related issues and develop solutions
- Prepare and maintain product documentation and compliance records
- Support import/export permits, certificates, and regulatory documentation
- Assist with maintaining compliance certifications and standards
- Work with government agencies and international associates when required
- Collect, analyze, and summarize data into reports and presentations
- Manage multiple assignments while meeting deadlines and quality standards
- Minimum 3 years of relevant experience or equivalent combination of education and experience
- Experience in quality systems, regulatory compliance, or documentation management preferred
- Project management experience is an added advantage
- Quality Systems Management
- Regulatory Documentation
- ISO & Medical Device Standards Knowledge
- Audit Support
- Data Analysis & Reporting
- Microsoft Excel & SAP
- Attention to Detail
- Time Management
- Problem Solving
- Communication Skills
- Team Collaboration
- Documentation & Record Management
- Bachelor's degree in Science, Engineering, or related technical discipline
- Basic understanding of quality systems regulations and medical device standards
- Ability to communicate effectively both verbally and in writing
- Ability to work independently and in cross-functional teams
- Strong analytical and organizational skills
- Professional certifications such as RAC or Six Sigma are a plus
- Knowledge of global regulatory standards is preferred
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