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.
Numbers & Facts
Location
Walker, MI
Industry
Biotechnology/Pharmaceuticals
Company Size
100 to 499 employees
Website
http://www.westpharma.com/
About Company
Leadership in Drug Administration Systems and Components Pharmaceutical, biopharmaceutical and medical device companies around the world rely on West Pharmaceutical Services, Inc. for standard-setting systems and device components for parenterally administered medicines.
West applies proprietary materials science, formulation research and manufacturing innovation to advance the quality, therapeutic value, development speed and rapid market availability of
pharmaceuticals, biologics, vaccines and consumer healthcare products.
Skills
Analysis Skillsunmatched
Computer Systemsunmatched
Corporate Policiesunmatched
Corrective Actionunmatched
Cost Controlunmatched
Customer Support/Serviceunmatched
Detail Orientedunmatched
Documentationunmatched
Experiment Designunmatched
GMP (Good Manufacturing Practices)unmatched
ISO 9000unmatched
Identify Issuesunmatched
Machine Toolunmatched
Manufacturingunmatched
Manufacturing Systemsunmatched
Manufacturing/Industrial Processesunmatched
Microsoft Officeunmatched
Organizational Skillsunmatched
Process Improvementunmatched
Product Designunmatched
Production Supportunmatched
Project Designunmatched
Quality Assurance Methodologyunmatched
Quality Controlunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Quality Metricsunmatched
Regulationsunmatched
Reporting Skillsunmatched
Safety/Work Safetyunmatched
Six Sigma Certificationunmatched
Standard Operating Procedures (SOP)unmatched
Statisticsunmatched
Trend Analysisunmatched
United States Department of Energy (DOE)unmatched
Willing to Travelunmatched
🎯
Be found by employers
5,500+ employers search our resume database daily. Add yours to get found by recruiters looking for candidates like you.
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.