Quality Engineer II, Pilot Receiving Inspection

Imagine how your ideas and expertise can change a patient’s life.  Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety.  You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle.  Your work will involve you optimizing product development to impact patients around the world with pioneering technology.  Edwards Lifesciences is excited to share a new opportunity for an Engineer II, Quality – Pilot Receiving Inspection, supporting Irvine Pilot Operations at the upfront stage of the value stream. In this role, you will help build, sustain, and improve Pilot Receiving Inspection to ensure incoming materials meet Edwards’ quality and compliance requirements before transfer to commercial Receiving Inspection.

How you will make an impact: 
•Assist Supplier Quality and Design Quality Assurance Engineers with part to product risk assessment and implement inspections in Irvine Pilot Receiving Inspection
•Coordinate with Planners and Receiving Inspection Supervisors to perform Engineering tasks required to move parts through Receiving Inspection
•Collaborate with Receiving Inspection commercial site to align on equipment for part inspection so that it is easily transferrable to transfer site.
•Identify opportunities for improvement, perform studies and implement improvements in the areas of inspection methods, sampling plans, automated data collection and process flow using six sigma/lean methodologies
•Investigate quality and compliance issues (e.g., CAPA, non-conformances, audit observations) and make part quality disposition decisions
•Develop training and documentation materials for part inspections to enable seamless knowledge transfer and ease of Inspector certification
•Implement Critical Control Points and perform preventative monitoring to ensure sustained part quality
•Assign tasks, give instructions, coach and train Technicians in support of Receiving Inspection including Equipment/Tooling Maintenance, Implementing new Inspections, Management of Quality Records, and performance of Test Method Validations
•Other incidental duties assigned by Leadership

What you'll need (Required):
•Bachelor's Degree in Engineering or Scientific field, 2 years’ experience related work experience or
•Master's Degree or equivalent in and internship, senior projects or thesis in Engineering or Scientific field including either industry or industry/education 

What else we look for (Preferred):
• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment required
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Solid problem-solving, organizational, analytical and critical thinking skills
• Solid understanding of processes and equipment used in assigned work
• Knowledge of and adherence to Quality systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
• Ability to build productive internal/external working relationships
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
 
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $87,000 - $123,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).  Applications will be accepted while this position is posted on our Careers website.   

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.