(Archived) Quality Engineer

Position Summary:

The Quality Engineer will be responsible for driving positive improvements in the quality of Zoetis BioDevices through implementation of sound Quality Engineering principles impacting supplier, in-house, and/or customer quality. This individual will be expected to perform with a high level of competency in quality management systems (QMS), corrective and preventative actions (CAPA), root cause analysis (RCA), and change control. This position reports directly to the Site Quality Lead and will work in a matrixed environment interacting closely with Suppliers, Planning, Engineering, Manufacturing, 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 in support of Durham QMS.
• 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 as well as 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.
• 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.
• Lead multi-functional teams in the investigation of failure, root cause, corrective and preventive action with regard to device installations.
• Control the release of software for devices.
• Conduct Gage R&R, bias/linearity studies or other statistical analysis as needed for problem-solving.

Organizational Relationships:

• Partners with Manufacturing, Engineering, Procurement, Device Planning, Technical Services, and Commercial teams to identify and address problems and opportunities in order to maximize and standardize product quality.

Education and 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
• Experience with supplier management and auditing
• 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
• 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