Senior Quality Engineer - Process & Data-Driven QA

West Pharmaceutical Services; Grand Rapids (MI); On-site; USD 85,000 - 120,000; Full time

Job summary

West Pharmaceutical Services seeks an engineering quality specialist to provide support on inspection, processing and managing non-conforming materials (NCMRs), and to assist production with quality issues and production process audits/inspections. The role also covers supplier collaboration on CAPAs and incoming inspection reporting.

You will work with ISO 9000 standards and GMPs, develop quality plans and documentation, and help refine testing methods while maintaining a clean, safe workspace.

Qualifications

• Bachelor’s degree in engineering or equivalent, plus 5+ years experience.
• Six Sigma certification preferred; MS Office proficiency required.

Responsibilities

• Recommends and performs quality controls, process testing and corrective action.
• Troubleshoot quality issues of production orders and support CAPAs.
• Monitor product quality data; analyze Cp/Cpk, DOE studies, and inspection reports.
• Provide status updates to customers and support engineering with quality plans.
• Develop design control deliverables and records for tooling/product history files.
• Ensure compliance with ISO 9000, GMPs, safety and company policies.

Skills

Six Sigma

Lean Sigma

ISO 9000 / GMP knowledge

MS Office proficiency

Education

Bachelor’s degree - Engineering Degree or equivalent

Tools

MS Office

Job description

West Pharmaceutical Services seeks an engineering quality specialist to provide support on inspection, processing and managing non-conforming materials (NCMRs), and to assist production with quality issues and production process audits/inspections. The role also covers supplier collaboration on CAPAs and incoming inspection reporting.

You will work with ISO 9000 standards and GMPs, develop quality plans and documentation, and help refine testing methods while maintaining a clean, safe workspace.