Quality Engineer

• 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 at an engineering, pharmaceutical, or medical device manufacturer 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 toolroom 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 Certification Upon Hire preferred and
• Manufacturing\Lean Six Sigma Black Belt with DOE experience. Upon Hire 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

West Pharmaceutical Services