Principal Supplier Quality Engineer

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.

The Principal Supplier Quality Engineer will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards’ systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

How you will make an impact:

• Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., SCARs (Supplier Corrective Action Reports), CAPAs, non-conformances, audit observations) for all production processes based on engineering principles; analyze results, make recommendations, and develop reports
• Lead supplier notification of change (NOC) projects, including having routine meetings with suppliers, lead cross functional teams to evaluate proposed changes and create a path for approval, execute the predefined tasks for approving the NOC, properly document the objective evidence for the NOC and acquire relevant approvals.
• Ensure validation methods of critical suppliers and incoming quality control are aligned with international standards, global regulations, and industry best practices.
• Lead the development and execution of complex experiments and test methods (including reviewing protocols and reports) to validate and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports and collaborate with team members to drive project completion.
• Perform supplier audits, act as Lead Auditor, and work with the supplier to perform proper root cause analysis to address audit findings using tools such as 5 Whys, DMAIC, PDCA, etc.
• Support necessary Product Risk Assessments for relevant complaints that affect supplier processes.
• Develop training and documentation materials for production (e.g., work instructions) to enable knowledge transfer of project and manufacturing processes.
• Train, coach, and guide lower-level employees on Supplier Quality procedures and responsibilities.
• Other incidental duties and initiatives assigned by Leadership.

What you’ll need (Required Qualifications):

• Bachelor’s degree in engineering or scientific field with 6 years of experience in Supplier Quality, Quality Engineering, or Manufacturing Engineering functions; OR a Master’s degree in engineering or scientific field with 5 years of experience in Supplier Quality, Quality Engineering, or Manufacturing Engineering functions
• Demonstrated Project Management Experience.
• Demonstrated leadership capabilities in coaching/guiding less seasoned engineers and teammates.
• Highly regulated industry experience
• Must have the ability to travel domestically and internationally (mostly domestic) between 10% – 25%

What else we look for (Preferred Qualifications):

• Engineering degree
• Medical Device industry experience
• Experience with supplier/vendor management and qualification activities with new suppliers, CMOs (Contract Manufacturing Organizations), or OEMs for new products.
• Experience with CAPAs, SCARs, NCRs, Change Notifications, and/or Auditing.
• Demonstrated experience driving component testing, test method validations, and testing/validating equipment.
• Well-versed in statistical tools such as Gage R&R, Statistical Process Control, Process Capability Studies, Hypothesis Testing, and other statistical techniques related to manufacturing.
• Demonstrated in-depth experience with risk management for validation qualifications (e.g. equipment or process IQ/OQ/PQs).
• Knowledge of the manufacturing process for injection molding, machining, and extrusions.
• Knowledge and understanding of FDA and international regulatory standards (i.e. ISO 13485 & ISO 14971) for medical devices.
• Six Sigma Green or Black Belt Certified and/or Certified Quality Engineer (CQE)

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.

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