Quality Engineer II

sgs-job-5957

Business Support
 Maryland
Quality Systems
GMP
Root Cause Analysis
ERP Systems
Microsoft Office/Suite

Contract - 3-Month Contract; High Possibility of Extension

Job type: 3-Month Contract; High Possibility Of Extension Weekly day range: Monday–Friday Shift Time: Standard business hours; exact shift not specified Quality Engineer II will support day-to-day business operations at the Columbia, MD site by working closely with Engineering and Operations teams on quality systems, change management, investigations, validation, preventive maintenance, calibration, environmental monitoring, and quality documentation. GMP experience in controlled/regulated environments is required, with Data Integrity experience being a major plus.

Job Responsibilities:

  • Support and maintain quality management systems and critical process control programs.
  • Manage change controls, including quality impact assessments, implementation planning, and completion of change records.
  • Lead and participate in quality investigations, including root-cause analysis, event reconstruction, corrective actions, and preventive actions.
  • Develop, review, edit, and approve SOPs, validation protocols/reports, quality plans, specifications, investigations, and other QMS documents.
  • Develop and review validation documentation for products, processes, and equipment.
  • Support calibration, preventive maintenance, environmental monitoring, and other critical control programs.
  • Support new/improved product and process launches and technology transfer from development to commercialization.
  • Perform statistical analysis, trending, sampling-plan development, and Statistical Process Control (SPC) activities.
  • Prepare monthly/quarterly quality trending and analysis reports.
  • Support Quality Management Review activities.
  • Participate in FDA inspections, ISO certification/surveillance audits, and customer audits.
  • Work cross-functionally with Engineering, Operations, Quality, and other teams to resolve problems and maintain compliance.
  • Work independently with minimal supervision while managing multiple quality activities

Skills:

  • GMP / GxP
  • Controlled / regulated manufacturing environments
  • Quality Engineering / Quality Assurance
  • Change Management / Change Control
  • Quality Investigations
  • Root Cause Analysis
  • CAPA
  • Validation
  • Data Integrity
  • 21 CFR Part 11
  • FDA QMSR / 21 CFR Part 820
  • ISO 13485
  • EU MDR / Regulation 2017/745
  • Calibration & Preventive Maintenance
  • Environmental Monitoring
  • Quality Systems / QMS
  • SOP / Protocol / Report Authoring
  • Statistical Analysis
  • Statistical Sampling Plans
  • Statistical Process Control / SPC
  • Data Trending
  • Quality Impact Assessments
  • Audit Support
  • Electronic Quality Management Systems / eQMS
  • ERP Systems
  • Microsoft Office/Suite
  • Data-driven decision making
  • Cross-functional problem solving
  • Project Management
  • Coding/Scripting or complex data-management validation — plus

Education/Experience:

  • Bachelor's degree in Science or related field required; Master's preferred.
  • Relevant experience may be considered in lieu of some education requirements.
  • Demonstrated experience working in GMP cleanrooms or controlled/regulated environments — MUST HAVE.
  • Experience in change management, data integrity, systems development/validation, or data integration/trending.
  • Understanding of statistically based sampling plans and analytical tools.
  • Demonstrated data-driven decision-making ability.
  • Strong organizational, communication, and project-management skills.
  • Ability to work independently with minimal supervision.
  • Knowledge of applicable quality/regulatory standards and international regulations.
  • ASQ, RAPS, or similar quality/regulatory certification preferred.
  • Experience with Data Integrity is a major differentiator/strong plus.
  • Medical device/manufacturing quality experience would be highly relevant given the ISO 13485, QMSR, and MDR requirements.

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