Fiscal Year

2020

Case Number

A-19204-34697

Case Status

Certified-Expired

Received Date

2019-08-27

Decision Date

2019-11-01

Refile

N

Original File Date

2020-01-01 07:41:27

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

13000

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

P10018332210237

PW SOC Code

17-2112

PW SOC Title

Industrial Engineers

PW Skill Level

Level IV

PW Wage

123115.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-04-10

PW Expiration Date

2019-07-09

Wage Offer From

123115.00

Wage Offer To

0.00

Average Salary

123115.00

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

Associate Manager, Quality

Job Title Slug

associate-manager-quality

Minimum Education

Master's

Major Field of Study

Biomedical Eng., Industrial Eng,, Quality Mgmt, Regulatory Sci. or related

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

N

Accept Alternative Combination Education

Accept Alternative Combination Education Years

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

60

Accept Alternative Job Title

progressive experience in quality systems management

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

In H.12. The requirements for the position are normal for the employer and within the industry. Employer marked not normal in H.12 due to ONET job zoneSVP analysis only.br br Work experience to include 1. Managing the execution of quality systems audits, including scheduling and tracking audits performed by internal auditors for a multisite organization; preparing and supporting audits performed by external agencies and regulators to include FDA and European Unions Notified Bodies; and providing system support for internal audits required by Quality Systems Regulations and standards to include 21 CFR 820 and ISO 13485 and performed by internal auditors. 2. Participating in phases in the execution of audit programs including defining and maintaining the processes for internal and external audits in the electronic audit management system and respective procedures and work instructions. 3. Conducting and reviewing CAPA investigations and their rootcause analysis, including review and tracking of action plans defined to address those root causes. 4. Investigating nonconformance issues and executing action plans in compliance with respective quality system regulations and standards to include 21 CFR 820 and ISO 13485. 5. Working within quality or manufacturing environment in the medical device industry. 6. Utilizing MS Office Suite Pivot tables to analyze and trend data resulting from quality systems audits and root cause investigations. 7. Working with regulations and standards related to quality management systems for the design, development, manufacturing and distribution of medical devices including FDA 21 CFR Part 820, ISO 13485, and ISO 14971. 8. Project management for the planning and rollout of new or modified quality management system process. Must include the use of MS Project software tools.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

2019-05-28

SWA Job Order End Date

2019-06-28

Sunday Edition Newspaper

Y

First Newspaper Name

Orange County Register

First Advertisement Start Date

2019-06-09

Second Newspaper Ad Name

Orange County Register

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-06-16

Employer Website From Date

2020-01-01 07:41:27

Employer Website To Date

2020-01-01 07:41:27

Professional Organization Ad From Date

2020-01-01 07:41:27

Professional Organization Advertisement To Date

2020-01-01 07:41:27

Job Search Website From Date

2019-06-10

Job Search Website To Date

2019-06-14

Employee Referral Program From Date

2019-06-05

Employee Referral Program To Date

2019-06-18

Local Ethnic Paper From Date

2019-06-10

Local Ethnic Paper To Date

2019-06-10

Radio/TV Ad From Date

2020-01-01 07:41:27

Radio/TV Ad To Date

2020-01-01 07:41:27

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

Master's

Foreign Worker Information: Major

INDUSTRIAL AND SYSTEMS ENGINEERING

Foreign Worker Years of Education Completed

2011

Foreign Worker Institution of Education

ROCHESTER INSTITUTE OF TECHNOLOGY

Foreign Worker Education Institution Address 1

1 LOMB MEMORIAL DRIVE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

ROCHESTER

Foreign Worker Education Institution State/Province

NY

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

14623

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