Responsible for reviewing design drawings, specifications, and processes with manufacturing to assure capability, compliance and quality and providing feedback internally on any changes that are required to operational success.
Monitor and analyze nonconformance reports and other performance data (i.e. incoming inspection data, CAPAs, FOI’s MQI’s, OTD, etc) for correlations and trends that could identify high-risk, recurring, or systemic issues and proactively report these quality performance statistics to internal stakeholders, including executive management.
Understand, audit, and continuously improve internal processes and process validations to assure internal product-realization processes are adequate to meet Edward’s quality requirements and specifications and produce quality components on time, every time.
Partner with internal process owners, Subject Matter Experts (SMEs), and stakeholders to initiate and facilitate 8D Corrective and Preventive Actions that ensure robust root cause analysis, complete and thorough containment, comprehensive implementation of corrective actions, and objective verification of the effectiveness of corrective actions to permanently address root cause.
Evaluate and determine reduced or increased inspection and/or audit plans based on risk assessment of internal performance, part/process criticality, and the effectiveness of existing supplier and internal Edwards controls.
Establish and enforce a proactive communication mechanism that will provide cross-functional process owners with a consistent, timely assessment of their performance and will invite internal feedback that may reduce costs and improve quality.
Comply with Safety Rules, Regulations and OSHA Requirements
Bachelor’s Degree in Science/Technical Discipline preferred, not required.
5 years of experience using quality tools (i.e. documentation support, root cause analysis, 8D, process auditing, inspection, process definition, continuous improvement) in an ISO 9001:2015 environment.
Knowledge and recent experience in process auditing, compiling/analyzing/reporting performance data, reading and understanding drawings/specifications/technical requirements, leading process improvement initiatives, facilitating the completion/close out of 8D CAPAs.
ASQ Certified Quality Engineer (CQE), Quality Auditor (CQI) preferred, not required.
10% of domestic and international travel required.
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