Manufacturing Quality Engineer - GMP/ISO (CAPA)

Stark Pharma Solutions Inc; Dover (DE); On-site; USD 90,000 - 115,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking a Manufacturing Quality Engineer to support manufacturing operations and ensure products meet quality, regulatory, and customer requirements.

The role collaborates with Manufacturing, Engineering, R&D, Validation, and Quality teams to identify and resolve quality issues. You will help maintain GMP compliance, participate in CAPA, change control, and risk assessments, and drive process improvements using Lean/Six Sigma.

Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or a related field.

Responsibilities

• Support day-to-day manufacturing quality activities and production operations.

Skills

Quality engineering

Root cause analysis

NCR handling

CAPA implementation

Process validation

GxP regulations

QMS familiarity

Lean Six Sigma

Statistical tools

Education

Bachelor's degree in Engineering

Tools

Veeva

TrackWise

MasterControl

SAP

Job description

Stark Pharma Solutions Inc. is seeking a Manufacturing Quality Engineer to support manufacturing operations and ensure products meet quality, regulatory, and customer requirements.

The role collaborates with Manufacturing, Engineering, R&D, Validation, and Quality teams to identify and resolve quality issues. You will help maintain GMP compliance, participate in CAPA, change control, and risk assessments, and drive process improvements using Lean/Six Sigma.