West Pharma Quality Engineer 

United States, Puerto Rico 

5557790

In this role, you will be responsible to control all Quality functions including the expansion and maintenance of the Quality System, provide support for product and process improvements by collecting, compiling, and analyzing inspection and process date, and ensure the effective use of resources to meet site quality requirements.

• Drive site and departmental goals/KPI’s in the improvement of Cost of Poor Quality and Yield Opportunity to 100%
• Meet Company and Department goals in the continuous improvement of tooling products, services, and processes
• Provide accurate quality reports and perform trend analysis on assigned areas of responsibility
• 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
• Support quality assurance improvement activities by evaluating products, processes, and data to develop control or improvement strategies intended to improve the Customer Experience
• Participate in the development and maintenance of product risk and hazard analysis (PFMEA)
• 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 and in-process SPC programs
• Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventative actions to preclude recurrence (CAPA)
• Identify and remedy equipment and/or process documentation gaps and provide appropriate training where needed
• Support both Corporate and facility driven initiatives intended to meet defined objectives, including Quality System planning and audit support
• Analyze data, process capabilities, customer concerns and expectations and any other leading or lagging indicators which may be used to improve product and process knowledge
• Interact with customers to understand and integrate those requirements into West manufacturing and quality system requirements
• Perform supplier non-conformance investigation and response
• Conduct activities in accordance with the company Quality Policies/Procedures at all times - Comply with company cGMP regulations and be responsible for defect recognition
• Schedule and maintain department machine calibration requirements and results
• Monitor and document daily output performance and unmanned hours in your department
• Perform other duties as assigned based on business needs
• Conform with and abide by all regulations, policies, work procedures, instructions, and all safety rules - exhibit regular, reliable, punctual, and predictable attendance

• Bachelor's Degree in Engineering, Business required

• Minimum 3 years of experience in a Quality engineering role in pharmaceutical, medical device manufacturing, or related regulated industry required and
• Minimum 3 years of experience in the use of computer-based measuring equipment (e.g., Coordinate Measuring Machine) required and
• Experience in conventional tool room machinery (mills, lathes, surfaces grinders) preferred

• Knowledge of ISO 9001, cGMP
• Proficiency in all Microsoft Office applications
• Flexibility in providing support beyond normal working hours when necessary
• Awareness of all relevant SOPs/SOIs as per Company policy as they are related to the position covered by this job description
• Always comply with the Company’s Safety and Quality Policies
• Trained Quality Auditor
• Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Formal apprenticeship or training in an engineering background
• Knowledge of SPC
• Knowledge of “Lean Manufacturing” techniques
• Knowledge and experience in all processes involved in the manufacture of rubber compression molds
• Qualified Lead Auditor
• Formal qualification in Quality Management

• Manufacturing\Six Sigma Green Belt or Black Belt Certification preferred

• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve and prioritize
• Self-motivated with the ability to make independent and sound judgments
• Read and interpret data, information, and documents
• Learn and apply new information or skills