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Case Number: A-21027-46383

Fiscal year: 2021

Fiscal Year

2021

Case Number

A-21027-46383

Case Status

Certified

Received Date

2021-04-05

Decision Date

2021-08-30

Refile

N

Original File Date

2021-01-01 10:05:55

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

FRESENIUS USA MANUFACTURING, INC.

Employer Name Slug

fresenius-usa-manufacturing-inc

Employer Address 1

920 WINTER ST.

Employer Address 2

Employer City

WALTHAM

Employer City Slug

waltham

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

2451

Employer Phone

(781) 699-9000

Employer Number of Employees

62679

Employer Year Commenced Business

1999

NAICS Code

334510

FW Ownership Interest

N

Employer Contact Name

Jeannine Foley

Employer Contact Address 1

920 Winter St.

Employer Contact Address 2

Employer Contact City

Waltham

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

2451

Employer Contact Phone

(781) 699-9459

Employer Contact Email

Jeannine.Foley@fmc-na.com

Agent Attorney Name

Victoria M Morte

Agent Attorney Firm Name

Parker Gallini LLP

Agent Attorney Phone

7818108990

Agent Attorney Address 1

460 Totten Pond Road

Agent Attorney Address 2

Suite 350

Agent Attorney City

Waltham

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2451

Agent Attorney Email

vmorte@parkergallini.com

PW Track Number

P10020118522191

PW SOC Code

11-3051

PW SOC Title

Quality Control Systems Managers

PW Skill Level

Level IV

PW Wage

115211.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-08-13

PW Expiration Date

2021-06-30

Wage Offer From

149198.40

Wage Offer To

0.00

Average Salary

149198.40

Wage Unit of Pay

Year

Worksite Address 1

475 W 13th Street

Worksite Address 2

Worksite City

Ogden

Worksite City Slug

ogden

Worksite State

UTAH

Worksite Postal Code

84404

Job Title

Senior Manager, Quality Systems

Job Title Slug

senior-manager-quality-systems

Minimum Education

Bachelor's

Major Field of Study

Chemical Engineering, Biological Engineering, Biomedical Engineering, or a closely 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

N

Accept Alternative Combination Education

Accept Alternative Combination Education Years

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

84

Accept Alternative Job Title

Experience providing Quality Systems oversight for medical device and pharmaceutical products

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

This position requires a Bachelors degree or equivalent foreign degree in Chemical Engineering, Biological Engineering, Biomedical Engineering, or a closely related field and 7 years of experience providing Quality Systems oversight for medical device and pharmaceutical products. Experience, which may have been gained concurrently with the primary experience requirement listed above, must include 5 years of experience with I Performing quality systems analysis in support of medical device products and ensure all products and processes comply with applicable regulations, including specifically cGMP regulations and ISO guidelines; II Providing recommendation for corrective action and preventative actions CAPA, and implementing continuous improvement processes; III drafting and preparing regulatory response and periodic updates of company products; IV developing budgets and capital requests as well as internal performance standards; and V Managing regional quality improvement projects.br br This position requires between 25 50 domestic and international travel.

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

2020-11-12

SWA Job Order End Date

2020-12-15

Sunday Edition Newspaper

Y

First Newspaper Name

Salt Lake Tribune

First Advertisement Start Date

2020-11-22

Second Newspaper Ad Name

Salt Lake Tribune

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-11-29

Employer Website From Date

2020-11-19

Employer Website To Date

2020-12-08

Professional Organization Ad From Date

2021-01-01 10:05:55

Professional Organization Advertisement To Date

2021-01-01 10:05:55

Job Search Website From Date

2020-12-07

Job Search Website To Date

2020-12-14

Employee Referral Program From Date

2021-01-01 10:05:55

Employee Referral Program To Date

2021-01-01 10:05:55

Local Ethnic Paper From Date

2020-12-04

Local Ethnic Paper To Date

2020-12-07

Radio/TV Ad From Date

2021-01-01 10:05:55

Radio/TV Ad To Date

2021-01-01 10:05:55

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

MEXICO

Foreign Worker Birth Country

MEXICO

Class of Admission

L-1

Foreign Worker Education

Bachelor's

Foreign Worker Information: Major

CHEMICAL ENGINEERING

Foreign Worker Years of Education Completed

2000

Foreign Worker Institution of Education

LA UNIVERSIDAD DE GUADALAJARA

Foreign Worker Education Institution Address 1

BLVD. MARCELINO GARCA BARRAGN

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

GUADALAJARA

Foreign Worker Education Institution State/Province

JALISCO

Foreign Worker Education Institution Country

MEXICO

Foreign Worker Education Institution Postal Code

44430

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Victoria M Morte

Preparer Title

Attorney

Preparer Email

vmorte@parkergallini.com

Employer Information Declaration Name

Jeannine Foley

Employer Information Declaration Title

Sr. Assoc., Global Mobility Immigration Programs