Fiscal Year

2024

Case Number

A-23034-97233

Case Status

Certified

Received Date

2023-03-17

Decision Date

2024-04-02

Refile

N

Original File Date

2024-01-01 00:57:57

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Fresenius USA Manufacturing, Inc., a Fresenius Me

Employer Name Slug

fresenius-usa-manufacturing-inc-a-fresenius-me

Employer Address 1

920 Winter Street

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

7816999459

Employer Number of Employees

62679

Employer Year Commenced Business

1999

NAICS Code

334510

FW Ownership Interest

N

Employer Contact Name

Molly Stout

Employer Contact Address 1

920 Winter Street

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

7816999459

Employer Contact Email

immigration@fmc-na.com

Agent Attorney Name

Donald W Parker

Agent Attorney Firm Name

Parker Gallini LLP

Agent Attorney Phone

7818108990

Agent Attorney Address 1

400 Fifth Avenue

Agent Attorney Address 2

Suite 401

Agent Attorney City

Waltham

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2451

Agent Attorney Email

dparker@parkergallini.com

PW Track Number

P10022076989030

PW SOC Code

17-2112.02

PW SOC Title

Validation Engineers

PW Skill Level

Level II

PW Wage

93808.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-12-15

PW Expiration Date

2023-06-30

Wage Offer From

101067.20

Wage Offer To

0.00

Average Salary

101067.20

Wage Unit of Pay

Year

Worksite Address 1

920 Winter Street

Worksite Address 2

Worksite City

Waltham

Worksite City Slug

waltham

Worksite State

MASSACHUSETTS

Worksite Postal Code

2451

Job Title

Supplier Quality Engineer

Job Title Slug

supplier-quality-engineer

Minimum Education

Bachelor's

Major Field of Study

Industrial Engineering, Manufacturing 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

24

Accept Alternative Job Title

Experience in quality engineering for the manufacture of medical devices or pharmaceutical products.

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

This position requires a Bachelors degree or foreign equivalent in Industrial Engineering, Manufacturing Engineering or a closely related field and two 2 years of experience in quality engineering for the manufacture of medical devices or pharmaceutical products.br br Experience, which may have been gained concurrently with the primary experience requirement above must include at least 2 years of experience inbr br Developing and validating engineering test methods and overseeing validation testing for the manufacture of medical devices and pharmaceutical products, including analyzing and reporting testing data.br Coordinating change controls and design control process.br Determining and evaluating product designs.br Performing risk analysis and audits.br Supporting new product registration with the US FDA and international regulatory agencies, including 510k, NDA, HDE, IDE, CE marks, and biocompatibility.br Working with Contract Manufacturing Organizations for Pharma and Medical devices Batch records review, Complaint investigations, review of deviation and nonconformances, validation activities, stability data review.br Applying working knowledge of applicable regulations and standards includingbr o FDA 21 CFR Part 820 Quality System Regulationbr o FDA 21 CFR Part 210211 Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs and Finished Pharmaceuticalsbr o ISO 13485 Quality Management systembr SAP ERP systems and Windchill Management softwarebr br This position requires 30 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

2022-12-13

SWA Job Order End Date

2023-01-17

Sunday Edition Newspaper

Y

First Newspaper Name

Boston Globe

First Advertisement Start Date

2022-12-18

Second Newspaper Ad Name

Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-12-25

Employer Website From Date

2022-12-13

Employer Website To Date

2023-01-02

Professional Organization Ad From Date

2024-01-01 00:57:57

Professional Organization Advertisement To Date

2024-01-01 00:57:57

Job Search Website From Date

2022-12-13

Job Search Website To Date

2022-12-20

Employee Referral Program From Date

2024-01-01 00:57:57

Employee Referral Program To Date

2024-01-01 00:57:57

Local Ethnic Paper From Date

2022-12-20

Local Ethnic Paper To Date

2022-12-22

Radio/TV Ad From Date

2024-01-01 00:57:57

Radio/TV Ad To Date

2024-01-01 00:57:57

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

INDUSTRIAL ENGINEERING

Foreign Worker Years of Education Completed

2014

Foreign Worker Institution of Education

INSTITUTO INTERNACIONAL DE ESTUDIOS SUPERIORES

Foreign Worker Education Institution Address 1

AVENIDA DEL PARQUE # 1000

Foreign Worker Education Institution Address 2

PARQUE INDUSTRIAL, VILLA FLORIDA

Foreign Worker Education Institution City

REYNOSA

Foreign Worker Education Institution State/Province

TAMPS.

Foreign Worker Education Institution Country

MEXICO

Foreign Worker Education Institution Postal Code

88710

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Donald W Parker

Preparer Title

Attorney

Preparer Email

dparker@parkergallini.com

Employer Information Declaration Name

Molly Stout

Employer Information Declaration Title

Supervisor, Global Mobility Immigration Programs