Quality Engineer II

SGS Consulting; Annapolis (MD); On-site; USD 90,000 - 120,000; Full time

Job summary

SGS Consulting in Annapolis, MD, is seeking a Quality Assurance professional to support and maintain GMP/GxP compliant quality systems across product and process lifecycle.

You will lead investigations, CAPA, change control, validation, data integrity, and audits, collaborating cross-functionally with Engineering, Operations and Regulatory teams to ensure compliance and continuous improvement.

Qualifications

• Bachelor's degree in Science or related field required; Master's preferred.

Responsibilities

• Support and maintain GMP/GxP quality systems.

Skills

GMP/GxP

Quality Assurance

Change Control

CAPA

Root Cause Analysis

Validation

Data Integrity

21 CFR Part 11

ISO 13485

MDR Regulation

Environmental Monitoring

SOP/Protocol Writing

Statistical Analysis

Audit Support

Quality Systems

Cross-functional Collaboration

Project Management

Data-driven Decisions

Education

Bachelor's degree in Science or related field

Master's degree preferred

GMP cleanrooms or regulated environments experience

Tools

eQMS

MS Office

Statistical software

Job description

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 / GxPControlled / regulated manufacturing environmentsQuality Engineering / Quality AssuranceChange Management / Change ControlQuality InvestigationsRoot Cause AnalysisCAPAValidationData Integrity21 CFR Part 11FDA QMSR / 21 CFR Part 820ISO 13485EU MDR / Regulation 2017/745Calibration & Preventive MaintenanceEnvironmental MonitoringQuality Systems / QMSSOP / Protocol / Report AuthoringStatistical AnalysisStatistical Sampling PlansStatistical Process Control / SPCData TrendingQuality Impact AssessmentsAudit SupportElectronic Quality Management Systems / eQMSERP SystemsMicrosoft Office/SuiteData-driven decision makingCross-functional problem solvingProject ManagementCoding/Scripting or complex data-management validation plusEducation/Experience:

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.