Job description
This Sr Manager will lead the Quality Operations function for THV (Transcatheter Heart Valve) programs as part of Global Supply Chain Pilot Manufacturing in Irvine. Will lead a team of Pilot QEs to work with new product development teams in the manufacturing of products for feasibility studies, clinical builds and first in human. Additional support within product transfer from the Pilot Operations into the commercial manufacturing facilities.Key Responsibilities:
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 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.
Lead test method validation activities and Process FMEAs for Pilot Manufacturing lines.
Support IQ/OQ/PQ for manufacturing equipment on 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.
Address product and process deficiencies through non-conformance and CAPA reports.
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.
Collaboration with R&D/NPD to identify DFM opportunities and develop process/inspection characterization strategies
Direct supervision and development of a group of Quality Engineers.
Education and Experience Requirements:
Bachelor's Degree in Engineering discipline with plus minimum 8 years relative quality engineering management within medical device industry.
Master's Degree (relative discipline) will offset two (2) years required experience.
Demonstrated record in management of technical and/or engineering disciplines
Preferred Qualifications:
Engineering experience with medical device implants and/or delivery systems
People leadership for teams of 3+ direct reports
Technical expertise in process development, statistics and/or software development/validation
Additional Talents and General Expectations:
- Proven record in project management leadership
- Advanced expertise using Lean and 6-sigma tools, Black Belt preferred
- Demonstrates a problem-solving, analytical and critical thinking mindset, including high discretion in decision making
- Professional documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
- People management experience including coaching and providing feedback, responsibility of employee actions including hire/fire authority and partnering with HR on employee relations
- Experience in development and integration of metrics into the projects and operations that clearly demonstrate the value of engineering to the business
- Ability to interact professionally with all organizational levels and develop relationships, leverage them to influence change
- Thrives in a dynamic and cross functional (matrixed) work environment
- Support and solicit input from team members at all levels within the organization
For California, the base pay range for this position is $123,000 to $174,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
About Edwards Lifesciences
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 13,000 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.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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