Senior Quality Engineer – Process Excellence & CAPA Lead

West Pharmaceutical Services, Inc; Walker (MI); On-site; USD 90,000 - 120,000; Full time

Job summary

West Pharmaceutical Services, Inc. is seeking a Senior Quality Engineer in Walker, MI to provide engineering support for inspection, non-conforming materials, and CAPAs while partnering with production on quality issues and audits.

The role requires a Bachelor’s degree in Engineering and 5+ years of experience in quality, with Six Sigma and ISO 9000/GMP knowledge valued. Strong MS Office skills and problem-solving abilities are essential for success.

Qualifications

• Bachelor’s degree - Engineering Degree or equivalent from four-year college or commensurate work experience
• 5+ years of experience in quality engineering
• Six Sigma certification preferred
• Experience with ISO 9000 standards and GMPs

Responsibilities

• Recommend and perform quality controls and corrective actions to protect product and process integrity.
• Troubleshoot quality issues on production orders.
• Monitor product quality data, identify trends, drive quality improvements.
• Analyze Cp/Cpk studies, DOE and other methods to determine mold qualification.
• Provide ongoing status updates with internal and external customers and support projects.
• Develop and refine quality plans and systems with engineering teams.
• Lead projects to improve product quality and reduce costs, including new inspection methods.
• Ensure compliance with regulations, policies, work procedures and safety rules.
• Maintain a customer service attitude when engaging with stakeholders.
• Keep workstation and environment clean, safe and organized.
• Create design control deliverables and records for tooling product history files.

Skills

MS Office

Six Sigma certification

Attention to detail

Education

Bachelor’s degree in Engineering

Tools

Quality tools

Job description

West Pharmaceutical Services, Inc. is seeking a Senior Quality Engineer in Walker, MI to provide engineering support for inspection, non-conforming materials, and CAPAs while partnering with production on quality issues and audits.

The role requires a Bachelor’s degree in Engineering and 5+ years of experience in quality, with Six Sigma and ISO 9000/GMP knowledge valued. Strong MS Office skills and problem-solving abilities are essential for success.