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 project

s

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 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 procedure

  s

  and

  provide

  train

  ing

  .  

  P

  rovide engineering support to Receiving Inspection on

  component

  test methodsand 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

  p

  roject

  m

  eetings and

  identify

  solutions to mitigate risks.

• Support process and system improvement projects as assigned by manager

What

you’ll

need

(Required)

:

• 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

  2

  5%

• 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, ISO13485, ISO9001, and other International Regulatory Standards.

• Experience and/or

  proficient

  k

  nowledge of

  Design Controls

  and

  test method development

  /

  validation

  s.

• 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

  throughCAPAs. 

• Knowledge of GD&T and ability to read and interpret drawings

  .

• Good u

  nderstanding of process validation

  s

  (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) 

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.

E

dwards 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.