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    At West Pharmaceutical Services, we're a dedicated team that's connected by a purpose to improve patient lives that has been at the center of our Company for more than a century.Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2.Through our work to deliver thousands of...

Quality Engineer

3 months ago


Walker, United States West Pharmaceutical Services Full time

This role is ONSITE in Grand Rapids, Michigan. Candidates applying must either be within a 50 mile radius of the site location or willing to relocate. Who We Are: At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts. Job Summary: Provide engineering support on duties such asinspection, 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. 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. Assumes responsibility for various assigned projects designed to improve product quality, reduce costs and/or validate facility products or 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. Other duties as assigned. Basic Qualifications: Education: College/ Bachelor's degree - Engineering Degree or equivalent from four-year college or commensurate work experience Experience: 3-5 years Highly proficient in MS Office applications. Preferred Knowledge, Skills and Abilities: Experience with ISO 9000 standards and GMP's. Six Sigma certification preferred. 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.