Quality Engineer

Quality Engineer

The Quality Engineer will be responsible for driving positive improvements in the quality of Zoetis BioDevices through implementation of sound Quality and Manufacturing Engineering principles impacting supplier, in-house, and/or customer quality. This individual will be expected to perform at a high level of competency in complaints, root cause analysis (RCA), and device support, including support during the final inspection of the completed device. This position reports directly to the Site Quality Lead and will work in a matrixed environment interacting closely with Suppliers, Engineering, Manufacturing, Field Service Specialists and Customers.

Position Responsibilities

• Provides subject matter expertise to achieve quality and cost objectives while meeting customer demands. Develop and implement processes, procedures and documentation to achieve quality objectives.
• Support End-to-End Quality Program including NCMRs, auditing, and metrics for internal/external suppliers and customer complaints. Provides Quality subject matter expertise to quality technicians and manufacturing.
• Manages all aspects of device release and qualification testing, including in-process inspections and testing and final inspection and testing. Ensures all documentation is complete before product release and addresses any gaps through Device Deviation process. Ensures compliance with customer-driven or regionally driven standards such as CE, ISO, etc.
• Conducts continuous improvement initiatives & interaction with internal customers and suppliers.
• Develops and maintains metrics for continuous improvement within QC and Manufacturing Operations.
• Works with applicable groups to conduct risk assessments to identify critical to quality components and processes and to establish appropriate test plans for commercial device release.
• Develops and maintains standards and methods for inspection, testing, and evaluation, utilizing knowledge from cross-functional quality, engineering and biological areas.
• Conducts RCA on any internal/external defects reported and establishes corrective action.
• Audits for potential non-conformances and establishes preventative action.
• Provides ongoing recommendations for cost reductions and performance improvements within the department and across the organization. Participates in cost reduction initiatives with manufacturing, procurement, and suppliers.
• Develop and document standardized work in the Assembly process through Work Instructions
• Lead multi-functional teams in the investigation of failure, root cause, corrective and preventive action with regard to device installations and complaints.
• Conduct Gage R&R, bias/linearity studies or other statistical analysis as needed for problem-solving
• Designs and implements manufacturing tooling, jigs, and fixturing

Organizational Relationships

• Works with Manufacturing, Engineering, Global Customer Support, Process Development, Device Planning, Technical Services, and Marketing to identify and address problems and opportunities in order to maximize and standardize product quality.
• Initiate/coordinate NCMRs, auditing, and metrics for internal/external suppliers, and external 3rd party assemblers.

Education & Experience

• Bachelors degree in Science or Engineering with 7+ years of experience required
• Minimum of 5 years experience within Manufacturing and/or Quality

Technical Skills Requirements

• Quality Engineer or Quality Auditor certification desired
• Ability to conduct process and system audits
• Ability to perform Gage R&R studies, calculate process capability and implement SPC
• Ability to interpret electrical schematics, mechanical drawings and knowledge of GD&T
• Ability to effectively drive systematic improvements within a structured approach.
• Experience drafting work instructions and inspection documents
• Experience with measurement equipment such as a CMM, Borescope, and Optical measuring equipment
• Must be proficient in Microsoft Office applications; Excel, Visio, PowerPoint, and Project
• Understanding of Lean and Six Sigma tools
• Experience with SAP software desired
• Ability to influence outcomes without direct authority
• Excellent written and oral communication skills

Physical Position Requirements

• Daily tasks involve office, lab and assembly environments
• Required to lift up to 35 lbs on a regular basis
• Travel expected up to 10%