Supplier Quality Engineer II, Process Validations & Test Methods

Edwards Lifesciences•Irvine, CA

2d•$87,000 - $123,000•Onsite

About The Position

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.

Requirements

Bachelor’s degree in engineering with at least 2 years of experience with either supplier quality, quality, manufacturing, R&D or production engineering activities; 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

Nice To Haves

Engineering degree
Medical Device, Aerospace, or Automotive industry experience.
Knowledge and understanding of FDA’s 21 CFR Part 820, ISO13485, ISO9001, and other International Regulatory Standards.
Experience and/or proficient knowledge of Design Controls and test method development/validations.
Experience with statistical techniques and tools such 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 applied through CAPAs.
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, while maintaining high attention to detail
Ability to achieve results in cross-functional team environment and build strong relationships with internal and external customers(suppliers)

Responsibilities

Facilitate/perform gage studies, process capability studies, and supplier process validations related to critical component features based on risks identified in FMEAs.
Develop and validate test methods, which can encompass creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using SolidWorks.
Create test method procedures and provide training. Provide engineering support to Receiving Inspection on component test methods and investigations.
Support component specification development, identification of critical features, development of inspection methods and plans, test method validation, process validations and component capability assessments
Supports risk 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 and project meetings and identify solutions to mitigate risks.
Support process and system improvement projects as assigned by manager