Senior Quality Engineer: CAPA, Validation & SPC Lead

West Pharmaceutical Services, Inc; Williamsport (Lycoming County); On-site; USD 80,000 - 110,000; Full time

Job summary

West Pharmaceutical Services, Inc. is seeking a Quality Engineer in Williamsport, PA to plan and execute quality activities, support product development, and drive CAPA across manufacturing, engineering and supply chain.

The role emphasizes root-cause analysis, measurement system validation and compliance with ISO 13485 and HACCP. Strong collaboration with customers and suppliers is required, with opportunities for travel as needed.

Qualifications

• Bachelor’s degree in a technical field such as Science, Engineering or Quality Assurance.
• 3+ years of quality or engineering experience in manufacturing.
• Experience with ISO 13485, HACCP and quality systems is preferred.

Responsibilities

• Plan, schedule and execute quality activities and customer communications.
• Support new product development and validation with Quality input.
• Lead audits and CAPA activities to improve plant operations.
• Perform root-cause analysis and implement corrective actions.
• Provide training on vision system operation and measurement routines.

Skills

Quality management

Statistical analysis

Root cause analysis

CAPA

SPC

Documentation

MS Office

Problem solving

Communication

Team collaboration

Education

Bachelor’s degree in technical discipline

Tools

SAP

MasterControl

Minitab

Calipers

Micrometers

Job description

West Pharmaceutical Services, Inc. is seeking a Quality Engineer in Williamsport, PA to plan and execute quality activities, support product development, and drive CAPA across manufacturing, engineering and supply chain.

The role emphasizes root-cause analysis, measurement system validation and compliance with ISO 13485 and HACCP. Strong collaboration with customers and suppliers is required, with opportunities for travel as needed.