Senior Quality Systems Engineer — QMS Leader (GxP)

Socket.dev; Easton (MD); On-site; USD 100,000 - 140,000; Full time

Job summary

Socket.dev is seeking a Senior Quality Systems Engineer to lead and maintain the Quality Management System within a regulated environment. You will drive CAPA, deviations, investigations, change control, risk management, audits, and document control while partnering with Manufacturing, Engineering, QC, Regulatory, and Quality Assurance teams.

The role emphasizes cross-functional leadership without direct reports, ensuring compliance with FDA, GMP/GxP, ISO, ICH, and Quality Agreements across

Qualifications

• Bachelor's degree in engineering, Chemistry, Biology, Life Sciences, or related technical discipline.
• Minimum 5 years of progressive experience in Quality Systems, Regulatory, or related functions in a regulated industry.
• Demonstrated experience with CAPA, deviations/nonconformances, investigations, change control, risk management, and audits.
• Experience working cross-functionally with Manufacturing, Engineering, QC, Validation, Regulatory, and Quality Assurance.
• Experience interpreting regulations (ISO 13485, ISO 14971, FDA 21 CFR Part 211, FDA 21 CFR Part 11, FDA 21 CFR Part 820), standards, procedures, and Quality Agreements.

Responsibilities

• Maintain and continuously improve the site's Quality Management System.
• Ensure QMS processes comply with applicable FDA, GMP/GxP, ISO, ICH, customer, and corporate requirements.
• Lead the complete CAPA lifecycle from initiation through effectiveness, verification, and closure.
• Support internal, customer, regulatory, notified-body, ISO, and third-party audits.
• Serve as a Quality Systems subject-matter expert during audits and inspections.
• Monitor KPIs for deviations, CAPAs, change controls, nonconformances, audits, suppliers, training, right-first time, and batch-first time performance.

Skills

Quality systems

CAPA

Root cause analysis

Audits

Regulatory understanding

Cross-functional collaboration

Documentation

ALCOA+

Education

Bachelor's degree in engineering/chemistry/life sciences

Tools

QMS software

Job description

Socket.dev is seeking a Senior Quality Systems Engineer to lead and maintain the Quality Management System within a regulated environment. You will drive CAPA, deviations, investigations, change control, risk management, audits, and document control while partnering with Manufacturing, Engineering, QC, Regulatory, and Quality Assurance teams.

The role emphasizes cross-functional leadership without direct reports, ensuring compliance with FDA, GMP/GxP, ISO, ICH, and Quality Agreements across