Fiscal Year

2024

Case Number

A-23051-03656

Case Status

Certified-Expired

Received Date

2023-02-22

Decision Date

2024-03-14

Refile

N

Original File Date

2024-01-01 00:57:19

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Abbott Diagnostics Scarborough Inc.

Employer Name Slug

abbott-diagnostics-scarborough-inc

Employer Address 1

10 Southgate Road

Employer Address 2

Employer City

Scarborough

Employer City Slug

scarborough

Employer State

MAINE

Employer State Slug

maine

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

4074

Employer Phone

8479378130

Employer Number of Employees

113000

Employer Year Commenced Business

1991

NAICS Code

325412

FW Ownership Interest

N

Employer Contact Name

Kathleen Ellwanger

Employer Contact Address 1

100 Abbott Park Road

Employer Contact Address 2

Dept. 32RC, Bldg. AP6A

Employer Contact City

Abbott Park

Employer Contact State/Province

ILLINOIS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

60064

Employer Contact Phone

8479378130

Employer Contact Email

kathleen.ellwanger@abbott.com

Agent Attorney Name

Keith P Liston

Agent Attorney Firm Name

Hussain Bendersky Liston LLC

Agent Attorney Phone

3124649330

Agent Attorney Address 1

1101 West Fulton Market

Agent Attorney Address 2

Suite 300

Agent Attorney City

Chicago

Agent Attorney State/Province

ILLINOIS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

60607

Agent Attorney Email

kliston@hebf.com

PW Track Number

P10022005809602

PW SOC Code

17-2112.02

PW SOC Title

Validation Engineers

PW Skill Level

Level I

PW Wage

49878.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-06-28

PW Expiration Date

2022-09-26

Wage Offer From

100000.00

Wage Offer To

110000.00

Average Salary

105000.00

Wage Unit of Pay

Year

Worksite Address 1

5 Bradley Drive

Worksite Address 2

Worksite City

Westbrook

Worksite City Slug

westbrook

Worksite State

MAINE

Worksite Postal Code

4092

Job Title

Manufacturing Quality Engineer

Job Title Slug

manufacturing-quality-engineer

Minimum Education

Bachelor's

Major Field of Study

Engineering

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Biotechnology, Chemistry, Life Sciences or in a closely related technical field of study. See H.14.

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

Professional Quality Engineering experience

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Bachelors or foreign equivalent degree in Engineering, Biotechnology, Chemistry, Life Sciences or in a closely related technical field of study with at least 2 years of professional quality engineering experience in i reviewing DHR for accuracy and completeness and provide guidance on FDA compliance and completion; ii facilitating or performing Nonconformance Reporting NCR and Corrective ActionsPreventative Action CAPA activities by completing risk assessments, root cause investigations, and action plans; iii performing Risk Management activities using Failure Mode Effect Analyses FMEAs, methodologies, including Design FMEA dFMEA and process FMEA pFMEA; iv Verification and Validation VV activities, including reviewing, authoring and approving Installation Qualification IQ, Operational Qualification OQ, Performance Qualification PQ, Process Performance Qualification PPQ, technical justifications, test protocols, and reports; v ensuring compliance with U.S. Food and Drug Administration FDA regulations and other regulatory requirements, particularly FDA 21 CFR 820, ISO 13485, and ISO 14971; vi conducting analyses using statistical techniques, including Gage Repeatability Reproducibility Gage RR, Tolerance intervals, and Process Capability assessments; and vii initiating Change Orders and authoring documentation for Process and Equipment Validation.

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

2023-01-20

Sunday Edition Newspaper

Y

First Newspaper Name

Maine Sunday Telegram

First Advertisement Start Date

2022-09-11

Second Newspaper Ad Name

Maine Sunday Telegram

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-09-18

Employer Website From Date

2024-01-01 00:57:19

Employer Website To Date

2024-01-01 00:57:19

Professional Organization Ad From Date

2024-01-01 00:57:19

Professional Organization Advertisement To Date

2024-01-01 00:57:19

Job Search Website From Date

2022-09-07

Job Search Website To Date

2022-09-21

Employee Referral Program From Date

2022-12-19

Employee Referral Program To Date

2023-01-06

Local Ethnic Paper From Date

2022-09-14

Local Ethnic Paper To Date

2022-09-20

Radio/TV Ad From Date

2024-01-01 00:57:19

Radio/TV Ad To Date

2024-01-01 00:57:19

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

INDIA

Foreign Worker Birth Country

INDIA

Class of Admission

H-1B

Foreign Worker Education

Master's

Foreign Worker Information: Major

ENGINEERING MANAGEMENT

Foreign Worker Years of Education Completed

2017

Foreign Worker Institution of Education

TRINE UNIVERSITY

Foreign Worker Education Institution Address 1

1 UNIVERSITY AVENUE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

ANGOLA

Foreign Worker Education Institution State/Province

IN

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

46703

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Keith P Liston

Preparer Title

Partner

Preparer Email

kliston@hebf.com

Employer Information Declaration Name

Kathleen Ellwanger

Employer Information Declaration Title

Senior Paralegal