Edwards Lifesciences
Quality Engineer Manager - Pilot Operations
USA - California – Irvine
Sponsorship not specified$121k-$171kDetected 2 days ago
StatisticsComplianceProject ManagementExcelSupply ChainMedical DevicesLeadershipCommunicationCollaborationProblem SolvingCritical ThinkingMentoring
About the role
- Our Quality team helps shape the development of groundbreaking technologies to ensure each stage of Edwards' innovation process is held to the highest standards of integrity and safety.
- How you will make an impact: • Direct supervision and development of a group of Quality Engineers.
Responsibilities
- Oversee the development of project plans and timelines, identify risks and develop contingency plans to meet project objectives.
- Lead test method validation activities and Process FMEAs for Pilot Manufacturing lines. Support IQ/OQ/PQ for manufacturing equipment on the Pilot lines.
- Collaboration with R&D/NPD (New Product Development) to identify DFM opportunities and develop process/inspection characterization strategies. Partner with Commercial Operations and NPD to implement and sustain best practices across the manufacturing network.
- Identify opportunities and lead the implementation of changes to drive improvements in the development of robust processes that assure quality products and services. Track performance and perform quality trend analysis to drive continuous improvement.
- Drive Implementation of Critical Control Points on Pilot product manufacturing lines consistent with Edwards CCP methodology.
- Support product transfer from Pilot to commercial manufacturing sites.
- Ability to manage technical and/or engineering disciplines and demonstrated informal mentoring and/or peer leadership skills
- Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
- Expert knowledge of design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods
- Develop relationships and leverage them to influence change
Requirements
- Bachelor's Degree in related field related experience in engineering
Skills
- Imagine how your ideas and expertise can change a patient's life.
Compensation
- For California (CA), the base pay range for this position is $121,000 to $171,000 (highly experienced).
Benefits
- Engineering experience with medical devices and/or delivery systems
Company info
- Responsible for the decision of release/rejection/disposition of all products manufactured as part of the Pilot Manufacturing lines. Address product and process deficiencies through non-conformance and CAPA reports.
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