Process Quality Engineer

Process Quality Engineer page is loaded## Process Quality Engineer locations:
Phoenix - CC17time type:
Full time posted on:
Posted Yesterday job requisition :
JR104185
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**** Position Summary
** The Process Quality Engineer ensures on-going product quality through continuous process and product monitoring, statistical analysis, and continual quality improvement initiatives.

The Process Quality Engineer is primarily responsible for the development and implementation of methods and procedures for process control, process improvement, testing and inspection to ensure that the products continue to meet design and product specifications. This role also performs statistical analysis to maintain quality levels and minimize defects and failure rates, including on-going review of Quality Control testing for material release and resulting data to determine trends and recommend corrective actions.

The Process Quality Engineer coordinates activities of the Material Review Board (MRB) and ensures appropriate material dispositions. The role collaborates as necessary, with operational stakeholders on quality problems, ensures that effective corrective actions are implemented and contributes to Operations Quality improvement programs.
** Job Responsibilities
*** Work closely with operations and the business functions to ensure quality performance of product and processes.
* Collaborates with Divisional QA, cross-functional groups, and supplier teams to address quality issues.
* Support implementation and/or verification of material and/or equipment specifications.
* Reviews incoming inventory material receiving records, and quality control testing documentation to release the materials for production use
* Accountable for Material and Product releases through review and release of kit manufacturing and batch manufacturing records
* Support execution of PFMEA, DFMEA and SOP generation associated with design transfers and product launch
* Support execution and analysis of manufacturing related complaints and product field actions.
* Execute internal quality deliverables associated with operational changes, manufacturing transfers and supplier-initiated changes.
* Participates and may lead change control management; creation and/or review of new or modified procedures.
* Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating appropriate actions as necessary.
* Own or support identified internal NCs, Deviations, Quality events, CAPAs, and manage to timely root cause investigation, implementation and closure.
* Work to introduce and implement Six sigma, process improvement, statistical and problem-solving tools and methodologies
* Support the development and review of production processes and for feedback through Measurement System Analysis (MSA) using DMAIC and tools.
* Applies statistical methods of analysis and process control to current operations.
* Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations.
* Responsible for initiation, internal containment, communication, and support of Commercial Holds for potential product escapes.
* Ensure adherence to GMP and safety procedures.
** Required Qualifications
*** Bachelor's degree in engineering/science or related discipline with 2+ years’…