Sr Quality Engineer

West Pharmaceutical Services•Walker, MI

10d•Onsite

About The Position

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. 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.

Requirements

Bachelor’s degree - Engineering Degree or equivalent from four-year college or commensurate work experience
Experience : 5+ years
Highly proficient in MS Office applications.

Nice To Haves

Six Sigma certification preferred.
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.

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.