Overview
Quality Control Engineer Jobs in Maryland, United States at EnIn Systems
Title: Quality Control Engineer
Company: EnIn Systems
Location: Maryland, United States
Key Responsibilities:
Conduct quality inspections, testing, and sampling of raw materials, in-process goods, and finished products.
Perform analytical and physical tests using validated methods and calibrated equipment.
Maintain and review quality documentation, including batch records, test results, and certificates of analysis (CoAs).
Report and investigate non-conformances, deviations, and OOS (Out of Specification) results.
Ensure compliance with cGMP, FDA, ISO 9001/13485, and other regulatory standards.
Calibrate and maintain lab instruments and ensure proper functioning.
Collaborate with Quality Assurance, Production, and R&D teams to resolve quality issues.
Participate in internal audits, CAPA activities, and process improvement initiatives.
Ensure Good Documentation Practices (GDP) in all QC records and logs.
Required Skills & Qualifications:
Bachelor’s degree in Chemistry, Life Sciences, Engineering, or related field.
2+ years of experience in quality control in pharmaceutical, biotech, medical devices, or manufacturing industry.
Hands-on experience with HPLC, UV-Vis, FTIR, pH meters, balances, and other laboratory equipment.
Knowledge of GMP, GLP, and ISO standards.
Strong analytical, organizational, and communication skills.
Preferred Qualifications:
Experience with LIMS, Empower, SAP, or other QC data management systems.
Knowledge of ICH guidelines and FDA regulatory requirements.
Certifications such as ASQ Certified Quality Technician (CQT) or Lean Six Sigma are a plus.
