Senior Quality Engineer - NPI & Tech Transfer

Socket.dev; Easton (MD); On-site; USD 110,000 - 160,000; Full time

Job summary

Socket.dev seeks a Senior Quality Engineer to oversee product quality across the lifecycle in its Liquid and Topicals Division, with emphasis on NPI and tech transfers into commercial operations.

The role requires 5+ years in a regulated environment (medical devices/pharma preferred), strong data analysis, and robust technical writing skills to drive CAPA and continuous improvement across manufacturing and packaging processes.

Qualifications

• Bachelor's degree in engineering or related scientific field.
• 5+ years of experience in an FDA-regulated industry (medical device/pharma preferred).
• Strong analytical, technical writing, and problem-solving skills.
• Experience with NPI, tech transfer, and quality lifecycle management.
• Knowledge of cGMP, ISO standards, and 21 CFR parts.

Responsibilities

• Drive tech transfers with cross-functional teams to ensure successful onboarding of new products.
• Lead root cause analysis of deviations and complaints with CAPA to prevent recurrence.
• Develop process workflows, FMEA, work instructions, and manufacturing/packaging documentation.
• Support supplier audits and monitor supplier quality performance.
• Track and trend material quality to reduce variation and drive continuous improvement.

Skills

Root Cause Analysis

FMEA

cGMP

Technical Writing

Data Analysis

Cross-functional Collaboration

Problem Solving

Quality Systems

Education

Bachelor's degree in engineering or related science

Tools

MS Office

ERP

eQMS

Job description

Socket.dev seeks a Senior Quality Engineer to oversee product quality across the lifecycle in its Liquid and Topicals Division, with emphasis on NPI and tech transfers into commercial operations.

The role requires 5+ years in a regulated environment (medical devices/pharma preferred), strong data analysis, and robust technical writing skills to drive CAPA and continuous improvement across manufacturing and packaging processes.