Edwards Lifesciences Senior Quality Engineer - External Manufacturing (USA Remote Position) in Irvine, California
This Senior Quality Engineer applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
Key Responsibilities :
Partner and interact with CMOs (Contract Manufacturing Organizations); manage any non-conformances with these manufacturers; and make sure the CMO’s quality standards and quality systems are in alignment with Edwards Lifesciences’ quality standards/systems.
Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., SCARs (Supplier Corrective Action Reports), CAPAs, non-conformances, audit observations) for all production processes based on engineering principles; analyze results, make recommendations, and develop reports
Initiate and participate in the completion of a Product Risk Assessment for relevant complaints. Attend and support Risk Management Council and Quality Review Board for Field Corrective Action decisions.
Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports and collaborate with team members to drive project completion
Lead in the identification and ensure the optimization of complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of more complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.Develop technical content of risk management files.
Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
Oversee Quality support tasks and mentor, train, coach, and provide instruction to less experienced engineers.
Identification of new CMOs including optimization of Edward’s supplier base. This includes improving, restricting, or exiting suppliers.
Other incidental duties
Required Qualifications :
Bachelor's Degree in Engineering or Scientific field with at least (4) years of quality/manufacturing experience; OR a Master's Degree in Engineering or Scientific field with at least (3) years of quality/manufacturing experience
Medical Device, Pharma, Automotive, or Aerospace industrial experience.
Preferred Qualifications :
Experience partnering with and managing Suppliers, specifically CMO and/or OEM and their activities
Manufacturing process controls knowledge and experience (process flow, FMEA, Control plans, Mistake Proofing, Statistical Process Control,).
Knowledge of DMAIC Six Sigma concepts with ability to apply to work product
Experience managing non-conformances, performing audits, and coordinating notification of changes with manufacturers
In-depth knowledge of Quality Management Systems and Processes
Demonstrated experience evaluating investigations; assessing and monitoring data from these investigations; and leading Quality Data Reviews with Suppliers
Good project management skills
Ability to identify areas or improvement and propose innovative ideas
Proven expertise in usage of MS Office Suite
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge)
Strong leadership skills and ability to influence change
Represents organization in providing solutions to difficult technical issues associated with specific projects
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.