Edwards Lifesciences Manager, Quality Engineering (Pilot - THV Programs) in Irvine, California
This position will lead the Quality Operations function for THV implants and delivery systems as part of Global Supply Chain Pilot Manufacturing in Irvine. The incumbent will interact with various functional departments to accomplish compliance and implementation of Quality goals with a primary focus to lead quality operations for pilot manufacturing. This position will work with new product development teams in the manufacturing of products for feasibility studies, clinical builds and first in human. This role will also support the product transfer from the Pilot Operations into the commercial manufacturing facilities.
Lead and manage quality improvement projects from initiation to completion to support Pilot Manufacturing. Oversee the development of project plans and timelines, identify risks and develop contingency plans to meet project objectives.
Tracks performance and performs quality trend analysis for quality operations, develop scorecards and key performance indicators to drive continuous improvement.
Support product transfer from Pilot to the manufacturing sites.
Drive Implementation of Critical Control Points on Pilot product manufacturing lines consistent with Edwards CCP methodology.
Ensures all processes are validated per Regulatory requirements to assure compliance and maintain the MVP for Pilot Manufacturing lines.
Support IQ/OQ/PQ for manufacturing equipment's in the Pilot lines.
Manages the process of formulating procedures, work instructions, for inspection processes across the Pilot Manufacturing lines. Responsible for the decision of release/rejection/disposition of all products manufactured as part of the Pilot Manufacturing lines.
Addresses deficiencies in quality operations, performance and delivery. Issues follow-up reports and corrective action reports and provides follow up and closure of nonconformance issues.
Utilizes lean manufacturing, error proofing and continuous improvement initiatives to support Pilot Manufacturing assisting in the development of robust processes that assures quality products and services.
Partner with Commercial Operations and New Product Development to implement and sustain best practices across the manufacturing network.
Direct supervision of a group composed by Quality Engineers and/or Analysts.
Education and Minimum Requirements:
• Bachelor's Degree in Engineering discipline with at least 8 years (or Master's with 6 years) within the medical device industry.
• Demonstrated track record in management of technical and/or engineering disciplines
Engineering experience with medical device implants and/or delivery systems
People leadership for teams of 3+ direct reports
Additional Talents and General Expectations:
• Proven successful project management leadership skills
• Deep knowledge and experience using Lean and 6-sigma tools, Black Belt preferred
• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Knowledge of financial acumen as it relates to engineering
• Demonstrated ability to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
• Ability to influence cross-functional partners, business units, and/or sites
• Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of engineering to the business
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• Develop relationships and leverage them to influence change
• Support and solicit input from team members at all levels within the organization
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.