Quality Engineer II: Process & Compliance Champion

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

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.