West Pharma Senior Quality Engineer 

Germany, North Rhine-Westphalia 

35472676

In this role, you will provide Quality Management System best practices across the programs you support. This role ensures regulatory and quality compliance and is responsible for planning, scheduling, executing and communicating all items regarding quality issues, complaints, validations and other projects in support of Customer Program Operations and product release. You may ensure suppliers deliver products which comply with requirements and specifications. You may lead efforts to enhance the supply chain by addressing supplier and customer issues, improving quality processes internally and with suppliers. You take on responsibilities in customer and supplier communication and actively implement West's quality policy at the Stolberg site.

• Investigation and processing of customer and supplier complaints
• Leading departmental projects for lean work structures
• Supporting internal and cross-factory projects
• Initiating and following quality-relevant processes in local Deviation and CAPA Management
• Conducting customer and supplier audits and processing related reports
• Implementing measures from audit processes with internal and external stakeholders
• Supporting factory functions in root cause analysis and implementation of corrective actions
• Managing relevant change processes according to West Change Control Policy
• Assisting in local training within the framework of quality initiatives
• Assisting in the creation of summaries and statistics for management
• Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS.
• Other duties as assigned

• Bachelor's Degree in Engineering or Science or equivalent experience required

• Minimum 5 years of professional experience in quality or a quality-related interface
• Proficiency in standard project management tools and software (e.g. Microsoft Project, Excel) for planning, tracking, and reporting project activities, and proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point required

• Proven knowledge in DIN ISO 9001:2015
• Very good MS Office and SAP skills
• Excellent German and English skills, both spoken and written
• Proficient use of statistical analysis tools (e.g., Minitab)
• Strong awareness of safety and organizational talent
• High teamwork capability and ability to act independently
• Strong problem-solving skills and project management experience
• Knowledge in DIN ISO 15378:2017 and Six Sigma Green Belt training are desirable

• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Excellent written and oral communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Strong problem-solving skills including root cause failure analysis methods.
• Critical reading skills and maintain high attention to detail, accuracy, and overall quality of work.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.