Fiscal Year

2020

Case Number

A-20100-41503

Case Status

Certified

Received Date

2020-04-29

Decision Date

2020-09-30

Refile

N

Original File Date

2020-01-01 19:59:17

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

EDWARDS LIFESCIENCES LLC

Employer Name Slug

edwards-lifesciences-llc

Employer Address 1

ONE EDWARDS WAY

Employer Address 2

Employer City

IRVINE

Employer City Slug

irvine

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

92614

Employer Phone

(949) 250-3444

Employer Number of Employees

14000

Employer Year Commenced Business

2000

NAICS Code

339112

FW Ownership Interest

N

Employer Contact Name

Nickie Engle

Employer Contact Address 1

ONE EDWARDS WAY

Employer Contact Address 2

Employer Contact City

IRVINE

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

92614

Employer Contact Phone

(949) 250-2947

Employer Contact Email

Nickie_Engle@edwards.com

Agent Attorney Name

Claudia P Martorell

Agent Attorney Firm Name

Larrabee Albi Coker LLP

Agent Attorney Phone

(858) 642-0420

Agent Attorney Address 1

P.O. Box 919016

Agent Attorney Address 2

Agent Attorney City

San Diego

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

92191-9016

Agent Attorney Email

cmartorell@larrabee.com

PW Track Number

P10019270064667

PW SOC Code

17-2112

PW SOC Title

Industrial Engineers

PW Skill Level

PW Wage

95064.00

PW Unit of Pay

Year

PW Wage Source

Other

PW Determination Date

2020-01-22

PW Expiration Date

2020-06-30

Wage Offer From

95064.00

Wage Offer To

0.00

Average Salary

95064.00

Wage Unit of Pay

Year

Worksite Address 1

One Edwards Way

Worksite Address 2

Worksite City

Irvine

Worksite City Slug

irvine

Worksite State

CALIFORNIA

Worksite Postal Code

92614

Job Title

Staff Quality Systems Analyst

Job Title Slug

staff-quality-systems-analyst

Minimum Education

Bachelor's

Major Field of Study

Industrial Engineering or a related field

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Master's

Accept Alternative Combination Education Years

5

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

72

Accept Alternative Job Title

progressive exp. in quality engineering, contd in H.14

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

In H.8A through C, in lieu of a Bachelors degree and 6 years of experience, employer will accept a Masters degree or equivalent in Industrial Engineering or a related field and 5 years of experience in quality engineering, quality operations, or quality systems or a combination of these fields.br br Contd from H.10B quality operations, or quality systems or a combination of these fields.br br Contd from H.12 The requirements for the position are normal for the employer and within industry. Employer marked Not Normal in H.12 due to ONet Job ZoneSVP analysis only.br br Work experience to include 1. Two years of experience as Lead Auditor for ISO 13485. Experience must be in the medical device industry. 2. Two years of experience conducting CAPA investigations, including performing and approving root cause analysis and investigations. 3. Working with FDA Quality System Requirements QSR, MDSAP Medical Device Single Audit Program, MHLV 169 Japan medical devices regulations, TGA Therapeutic Goods Administration, Australia, RDC 16 Good Manufacturing Practices Regulations, Brazil and 9342EEC European Union Directives on Medical Devices. 4. Preparing written reports and presentations for management and internal customers or stakeholders. 5. Conducting auditrelated compliancerelated, qualityrelated training to technical and nontechnical personnel. 6. Utilizing MS Office to analyze and trend data resulting from internal and external audits. Any and all experience can be gained concurrently.br Hiring Requirements Drug TestingScreening, Background Checks.

Combination Occupation

N

Offered to Applicant Foreign Worker

Y

Foreign Worker Live on Premises

N

Foreign Worker Live in Domestic Service

N

Foreign Worker Live in Domestic Service Count

Professional Occupation

Y

Application for College/University Teacher

N

SWA Job Order Start Date

2020-01-30

SWA Job Order End Date

2020-03-02

Sunday Edition Newspaper

Y

First Newspaper Name

Orange County Register

First Advertisement Start Date

2020-01-26

Second Newspaper Ad Name

Orange County Register

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-02-02

Employer Website From Date

2020-01-01 19:59:17

Employer Website To Date

2020-01-01 19:59:17

Professional Organization Ad From Date

2020-01-01 19:59:17

Professional Organization Advertisement To Date

2020-01-01 19:59:17

Job Search Website From Date

2020-01-27

Job Search Website To Date

2020-01-31

Employee Referral Program From Date

2020-01-01 19:59:17

Employee Referral Program To Date

2020-01-01 19:59:17

Local Ethnic Paper From Date

2020-01-27

Local Ethnic Paper To Date

2020-01-27

Radio/TV Ad From Date

2020-01-01 19:59:17

Radio/TV Ad To Date

2020-01-01 19:59:17

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

DOMINICAN REPUBLIC

Foreign Worker Birth Country

DOMINICAN REPUBLIC

Class of Admission

L-1

Foreign Worker Education

Bachelor's

Foreign Worker Information: Major

INDUSTRIAL ENGINEER

Foreign Worker Years of Education Completed

2007

Foreign Worker Institution of Education

MOTHER AND TEACHER PONTIFICAL CATHOLIC UNIVERSITY

Foreign Worker Education Institution Address 1

ABRAHAM LINCOLN ESQ. SIMN BOLVAR

Foreign Worker Education Institution Address 2

LA JULIA

Foreign Worker Education Institution City

SANTO DOMINGO

Foreign Worker Education Institution State/Province

Foreign Worker Education Institution Country

DOMINICAN REPUBLIC

Foreign Worker Education Institution Postal Code

10109

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Claudia P Martorell

Preparer Title

PartnerAttorney at Law

Preparer Email

Claudia@larrabee.com

Employer Information Declaration Name

Heather Sheira

Employer Information Declaration Title

Sr. Manager, Global Mobility