Sr Quality Engineer

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

Job Summary

• Recommends and performs appropriate quality controls, process testing and corrective action as needed to insure product and process integrity.
• Troubleshoot quality issues of production orders.
• Monitor and track product quality data, identify existing trends, drive quality improvement efforts, offer suggested conclusions and recommend follow-up action.
• Analyze, generate, and report findings from Cp/Cpk studies, window studies, DOE’s (design of experiment), first article inspection reports and other analytical/statistical methods to determine mold qualification.
• Provides on-going status follow-up with internal and external customers to support projects and programs.
• Provides ongoing assistance to engineering by establishing and refining quality plans and systems.
• Assumes responsibility for various assigned projects designed to improve product quality, reduce costs and/or validate facility products of processes, including development and implementation of any new or required inspection methods.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Provides a "Customer Service" attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintains a clean, orderly, and safe workstation and environment at all times.
• Work independently and with project teams to develop design control deliverables including quality plans, manufacturing and inspection documentation, test methods, and any necessary records for filing tooling product history files.

Description

Job Summary

Provide engineering support on duties such as inspection, processing and managing non-conforming materials (NCMRs), supporting production with quality issues and production process audits/inspections as well as supporting incoming inspection and reporting and working with suppliers on CAPAs.

Essential Duties And Responsibilities

• Recommends and performs appropriate quality controls, process testing and corrective action as needed to insure product and process integrity.
• Troubleshoot quality issues of production orders.
• Monitor and track product quality data, identify existing trends, drive quality improvement efforts, offer suggested conclusions and recommend follow-up action.
• Analyze, generate, and report findings from Cp/Cpk studies, window studies, DOE’s (design of experiment), first article inspection reports and other analytical/statistical methods to determine mold qualification.
• Provides on-going status follow-up with internal and external customers to support projects and programs.
• Provides ongoing assistance to engineering by establishing and refining quality plans and systems.
• Assumes responsibility for various assigned projects designed to improve product quality, reduce costs and/or validate facility products of processes, including development and implementation of any new or required inspection methods.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Provides a "Customer Service" attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintains a clean, orderly, and safe workstation and environment at all times.
• Work independently and with project teams to develop design control deliverables including quality plans, manufacturing and inspection documentation, test methods, and any necessary records for filing tooling product history files.

Education

• Bachelor’s degree - Engineering Degree or equivalent from four-year college or commensurate work experience

Work Experience

• Experience: 5+ years
• Six Sigma certification preferred.
• Highly proficient in MS Office applications.

Preferred Knowledge, Skills And Abilities

• Experience with ISO 9000 standards and GMP’s.
• Excellent organizational skills with close attention to detail and accuracy.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Working knowledge of latest quality tools and systems.
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times .

Travel Requirements

• None.

Physical Requirements

• Able to comprehend mechanical drawings, computer systems and manufacturing processes.