Supplier Quality Engineer II, Process Validations & Test Methods

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 Supplier Quality Engineer II will play a key role on critical projects within the Transcatheter Mitral & Tricuspid Therapies (TMTT) 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 leading successful part qualification efforts with external suppliers to support product development 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**  **:*
* + Facilitate/perform gage studies, process capability studies, and supplier process validations related to criticalcomponentfeatures based on risksidentifiedin FMEAs.

+ Developandvalidatetest methods, which can encompass creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using Solid Works.

+ Create test method proceduresandprovidetraining.  Provide engineering support to Receiving Inspection oncomponenttest methods and investigations.

+ Supportcomponentspecification development, identification of critical features, development of inspection methods and plans, test method validation,processvalidationsandcomponentcapability assessments

+ Supportsrisk management activities, including the development and implementation of FMEAs, process control plans, and quality agreements at suppliers

+ Utilize statistical techniques and six sigma tools to analyze processes and drive continuous improvement activities

+ Conduct on-site supplier audits.

+ Manage supplier-related non-conformances.

+ Manage supplier corrective action requests from initiation to closure.

+ Collect and analyze Quality metrics relating to Supplier Quality

+ Communicate supplier quality risks to upper management during Management Review andprojectmeetings andidentifysolutions to mitigate risks.

+ Support process and system improvement projects as assigned by manager

** What*
* ** you'll*
* ** need**   **(Required)**  **:*
* + Bachelor's degree in engineeringwith at least 2 years of experience witheithersupplier quality,quality,manufacturing,R&Dorproductionengineeringactivities; OR Master's degree with no experience (or internship/co-op experience).

+ Highly regulated industry experience

+ Must have ability to travel up to 25%

+ Ability to work 100% onsite at our Irvine, CA location. This role is not eligible for remote or hybrid work arrangements

** What else we look for**   **(Preferred)**  **:*
* + Engineering degree

+ Medical Device, Aerospace, or Automotive industry experience.

+ Knowledge and understanding of FDA's 21 CFR Part 820, ISO
13485, ISO
9001, and other International Regulatory Standards.

+ Experience and/orproficientknowledge of Design Controlsandtest method development/validations.

+

Experience with statistical techniques and toolssuch as Gage R&R, Statistical Process Control, or Process Capability Studies.

+ Ability to conduct effective root cause analysis; driving non-conformance investigations; and assessment of corrective action strategies and effectiveness as appliedthroughCAPAs.

+ Knowledge of GD&T and ability to read and interpret drawings.

+ Good understanding of process validations(IQ, OQ, PQ)

+ Good understanding of manufacturing processes (i.e., injection molding, extrusion, machining, etc.).

+ Good interpersonal skills, with the ability to negotiate and influence change.

+ Possess the ability to multi-task, whilemaintaininghigh attention to detail

+ Ability to achieve results in cross-functional team environment and build strong relationships with internal and external customers(suppliers)

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 $87,000 to $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.