West Pharma Sr Engineer Complaints/Product Analysis 

United States, Arizona, Scottsdale 

840101077

Job Summary:

In this role, you will work under the direction of the Product Analysis Manager to support activities related to product root-cause failure investigations on electro-mechanical drug delivery devices and other related products. You will additionally drive lean initiatives on the investigation process, manage communication with internal and external customers, and train team members on new devices.

Essential Duties and Responsibilities:

• Utilizes on the job experience, critical thinking skills, and root cause analysis methodologies to assist lab technicians with atypical and/or complex root cause determination.
• Independently performs investigations to determine root cause for customer received complaints pertaining to issues beyond device functionality; including but not limited to manufacturing, shipping and receiving, production environment, and labeling.
• Is proficient in the use and maintenance of laboratory test equipment necessary for conducting root-cause investigations, such as Instron, CT scanner, oscilloscope, power supply, multi-meter, microscopes.
• Is proficient in the process of conducting root cause investigations.
• Has effective technical writing skills and is able to communicate findings in a technical, concise, and effective manner with little to no assistance. Documents investigation reports per procedures.

• Assists the Product Analysis Manager with:

• Review and approval of other technician’s investigation reports
• Training technicians on the investigation processes and use of laboratory equipment.
• Performing daily, weekly, and/or monthly tracking and trending activities related to complaints and other lab metrics.
• New customer onboarding
• Complaint-handling process improvements / lean initiatives.

• Communicates investigation results to customers and aids in management of customer relationships.
• Contributes to the design and development of new tests and debugging methods.
• Identifies critical product issues. Assists with Issue Reviews and Corrective & Preventive Actions (CAPAs) when necessary. Contacts appropriate support and/or management to ensure issues are reported and resolved.
• Creates and maintains a clean, neat, and safe work environment through identifying and resolving potential safety hazards.
• Facilitates teamwork and collaboration between departments to maximize processes and resolve problems.
• Demonstrates a “Customer Service” approach to all activities and assignments.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Complies with the company’s safety and quality policies at all times, including proper handling of biohazard materials and components.

• Exhibits regular, reliable, punctual and predictable attendance .

Basic Qualifications:

• Education: Minimum of Bachelor's in Science or Engineering
• Experience: Minimum 5-8 years of experience

• Demonstrated ability to:
  • Prioritize and complete multiple tasks. Has effective time management skills and can easily adapt to changes in priorities; needs little to no assistance in determining priorities and deliverables.
  • Understand and communicate technical ideas and concepts with technical and non-technical audiences (written and verbal)

Preferred Knowledge, Skills and Abilities:

• Experience in conducting root cause investigations of field units.
• Experience in laboratory test equipment operation and maintenance such as Instron, CT scanner, oscilloscope, power supply, multi-meter, and microscopes.
• Experience in a manufacturing environment.
• Background in medical device or pharmaceutical industry.
• Knowledge of Quality Management System regulations
• Knowledge of lean manufacturing and operational excellence concepts.

Travel Requirements:

• No recurring travel requirements. May be asked to travel up to 5% of the time.

Physical and Mental Requirements:

• Must be able to work assigned shift(s) with overtime as required to complete assignments if necessary.
• Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.
• If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear and react to audible alarms from distances up to 150 feet.
• The ability to lift and carry various items up to 50 pounds for manufacturing positions or 30 pounds for administrative positions as required.
• Handling of biohazard materials/components and potent drug compounds.