Supplier Quality Engineer II, New Product Development

**Please note this is an onsite role, and the successful candidate will be expected to work from our corporate Irvine, CA campus.

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. 

This Supplier Quality Engineer II position will play a key role on critical projects within the THV business unit. This position is cross-functional in nature and requires strong collaboration and partnership with R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering and Receiving Inspection. The primary focus of the position is supporting and/or leading successful part qualification efforts with external suppliers to support product development, process improvement and commercial launch timelines. The Supplier Quality Engineer II will work on-site in a very fast-paced and dynamic environment where being proactive and taking initiative are paramount to success.

 How you will make an impact:

• Perform supplier evaluations including on-site audits to assess supplier capabilities, determine approval status, and verify corrective action
• Develop and validate test methods, which can encompass creating inspection plans utilizing optical measurement equipment, handtools, CMM, etc. and design and creation of inspection fixtures
• Facilitate/perform gage studies, process capability studies, and supplier process validations related to critical component features based on risks identified in FMEAs.
• Conduct component and product quality testing for purposes of supplier and component qualification and improvement
• Identify and implement statistical engineering tools and techniques to evaluate supplier process capability and technical performance
• Collect and analyze quality metrics relating to Supplier Quality
• Identify and define correction actions and follow-up to ensure completeness and effectiveness
• Communicate supplier quality risks to upper management while suggesting improvements and cost savings where possible
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and inspection processes.
• Conduct on-site supplier audits.
• Manage supplier-related non-conformances.
• Manage supplier corrective action requests from initiation to closure.
• Report on supplier part qualification status at recurring cross-functional project meetings
• Implement process improvement projects to standardize and increase efficiency

What you’ll need (Required Qualifications):

• Bachelor’s degree in Engineering or Scientific field with at least 2 years of experience with supplier quality, manufacturing, or quality engineering functions; OR Master’s degree in Engineering or Scientific field with no experience (or internship/co-op experience).
• Highly regulated industry experience

What else we look for (Preferred Qualifications):

• Engineering degree
• Experience with supplier quality engineering activities, including external supplier vendor audits
• Effective problem-solving techniques (i.e. Root Cause Analysis, FMEA process, Gage R&R, Validation activities, etc.)
• Conduct effective root cause investigations; assessment of corrective action strategies; and effectiveness as applied to NCRs and SCARs
• Experience with class II and class III medical devices
• Knowledge of Power BI, excel macro coding, Microsoft power automate
• Medical device, pharma, or biotech industry experience
• Demonstrated ability to apply statistical quality engineering tools in a supplier environment
• Working knowledge of International and Domestic FDA regulations
• Solid problem-solving, organizational, analytical and critical thinking skills
• Effective communication and conflict resolution skills
• Thorough understanding of Risk Management principles
• Strong communication and organizational skills to effectively manage and get results with external suppliers
• Six Sigma Black Belt/LEAN Manufacturing experience
• ASQ Certified Quality Engineer or ASQ/BSI Certified Quality Auditor 

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 (CA), the base pay range for this position is $85,000 to $120,000 (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.