Principal Engineer, Global Supplier Quality

**Please note this position is eligible to have a “hybrid” work schedule.  The successful candidate will be expected to work onsite 3 days per week from our corporate Irvine, CA campus and work remotely 2 days per week.

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. 

We are seeking a Principal Supplier Quality Engineer to join our Corporate Quality organization supporting Global Supplier Quality.  This role will conduct surveillance audits (Domestic and Global Suppliers), support qualification and performance audits as requested, lead closure activities for Supplier Qualification Requests (SQRs) related to clinical, software, and Edwards Quality Laboratory (EQL) suppliers, and collaborate on other Supplier Management projects as requested by Corporate Quality management.  This is a fast-paced and dynamic role, where taking initiative, strategic problem-solving, and collaborating cross-functionally is critical for success.  The Principal Supplier Quality Engineer will apply knowledge of quality engineering principles to optimize audit processes and other qualifying activity processes related to supplier quality and supplier management. 

How you will make an impact:

• Lead thorough audits of supplier manufacturing processes, products, and quality systems, ensuring compliance with regulations and identifying areas for improvement to maintain product quality and customer satisfaction throughout the supply chain. The supplier includes manufacturing, machining, molding, and service providers – sterilization, calibration, preventive maintenance (PM service), etc.
• Lead all pre-audit activities including creating audit plans and audit agendas.
• Participate in creating and executing the Global Supplier Audit Plan and manage various activities for executing and closing assigned audits.
• Report on the status of the Global Supplier Audit Plan to upper management.
• Supports qualification initiatives, continuous improvement, and regulatory compliance activities across all sites.
• Support internal & external stakeholders (including suppliers) on a daily basis and during external audits by notifying bodies (e.g., DEKRA, TUV, BSI, etc.).
• Responsible for ensuring compliance with all Federal, State, local, and company regulations, policies, and procedures.
• Lead efforts to resolve issues and drive innovative solutions with suppliers.
• Investigate complex adverse events in partnership with suppliers (e.g., audit findings, NCRs, SCARs, etc.) and drive implementation of effective solutions using best practices.
• Serve as a quality resource and technical expert on cross-functional teams or projects.
• Communicate effectively with stakeholders at all levels, translating technical information.
• Work in a team environment, with the capability to lead cross-functional projects.
• Perform other responsibilities as assigned.

What you’ll need (Required Qualifications):

• Bachelor’s degree in engineering or scientific fields with (6) years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality Engineering functions; OR Master’s degree in engineering or scientific fields with (5) years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality Engineering functions.
• Demonstrated experience leading and managing supplier audits, SCARs, NCRs, and coordinating notifications of change with suppliers.
• In-depth knowledge and understanding of FDA and international regulatory standards for medical devices (i.e., ISO 9001, ISO 13485, ISO 17025, etc.)
• Ability & willingness to travel domestically and internationally up to 50%.

What else we look for (Preferred Qualifications):

• Proven experience with Supplier Quality, Vendor Management, and Project Management.
• Strong root cause investigation skills.
• Knowledge and understanding of additional relevant standards for manufacturing medical devices (e.g., 21 CFR Part 820, EU MDR, ISO 17025, ISO 14644, 21 CFR Part 58, ISO 11135, ISO 11137, etc.).
• ISO 13485 or ISO 9001 Lead Auditor certification from a recognized body (e.g., CQA from American Society of Quality (ASQ), BSI, RAB/Exemplar, IRCA, or any other accredited program).
• Excellent communication and organizational skills to effectively manage and obtain buy-in from internal & external stakeholders.
• Ability to work independently while exercising considerable latitude in making significant decisions.
• Green Belt / Black Belt certification.
• In-depth understanding and experience with risk management for validation/qualifications (e.g. equipment &/or process OQ/PQs).
• Strong understanding of manufacturing processes (ex. injection molding, extrusion, machining, sterilization, calibration, clean rooms, contract manufacturing, receiving inspection, etc.)

For California, the base pay range for this position is $136,000 to $192,000 (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.