Fiscal Year

2024

Case Number

A-22258-21735

Case Status

Certified-Expired

Received Date

2022-11-18

Decision Date

2023-10-04

Refile

N

Original File Date

2024-01-01 00:02:09

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

ASTRAZENECA PHARMACEUTICALS LP

Employer Name Slug

astrazeneca-pharmaceuticals-lp

Employer Address 1

1800 CONCORD PIKE

Employer Address 2

Employer City

WILMINGTON

Employer City Slug

wilmington

Employer State

DELAWARE

Employer State Slug

delaware

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

19897

Employer Phone

302-886-3000

Employer Number of Employees

83100

Employer Year Commenced Business

1966

NAICS Code

32541

FW Ownership Interest

N

Employer Contact Name

Echeverri Adriana

Employer Contact Address 1

One MedImmune Way

Employer Contact Address 2

Employer Contact City

Gaithersburg

Employer Contact State/Province

MARYLAND

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

20878

Employer Contact Phone

301-398-0209

Employer Contact Email

adriana.echeverri@astrazeneca.com

Agent Attorney Name

Hyla K Rosenberg

Agent Attorney Firm Name

Fragomen, Del Rey, Bernsen Loewy, LLP

Agent Attorney Phone

2126888555

Agent Attorney Address 1

1400 Broadway

Agent Attorney Address 2

Agent Attorney City

New York

Agent Attorney State/Province

NEW YORK

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

10018

Agent Attorney Email

svialva@fragomen.com

PW Track Number

P10021252574594

PW SOC Code

17-2199.00

PW SOC Title

Validation Engineers

PW Skill Level

Level IV

PW Wage

162157.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-04-25

PW Expiration Date

2022-07-24

Wage Offer From

165000.00

Wage Offer To

0.00

Average Salary

165000.00

Wage Unit of Pay

Year

Worksite Address 1

One MedImmune Way

Worksite Address 2

Worksite City

Gaithersburg

Worksite City Slug

gaithersburg

Worksite State

MARYLAND

Worksite Postal Code

20878

Job Title

Principal Design Quality Engineer

Job Title Slug

principal-design-quality-engineer

Minimum Education

Bachelor's

Major Field of Study

Engineering (any) or a related field

Required Training

N

Required Experience

Y

Required Experience Months

120

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

8

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

96

Accept Alternative Job Title

Design Quality Engineer or a related position

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Must have a Bachelors degree or foreign equivalent in Engineering any or a related field plus ten 10 years of progressively responsible experience in the position offered as a Design Quality Engineer or a related position.br Must have ten 10 years of progressively responsible experience in each of the following US and International Design Control and Risk Management requirements including 21 CFR Parts 4, 210, 211, 803, 806, 820.30, ISO 13485, ISO 14971, and EU Medical Device Regulations; Risk assessment tools, including Failure Mode and Effect Analysis tools, Fault Tree Analysis, and Hazard Assessment; Authoring technical specifications and design control documentation including Design Development Plan, User Requirements Specification, Design Input Specification, Design Outputs, Design Reviews, Design Verification Master Plan and Reports, Design Validation PlanReport, Design Transfer and Verification PlansReports, Human Factors studies Formative, Summative and Summary PlanReports, Risk Management Suite Risk Management PlansReports, Use Failure Mode and Effect Analysis, Design Failure Mode and Effect Analysis, Design Master Records, and conformity assessments; Providing quality engineering support for the investigation and trending device designrelated complaint records using relevant techniques including 5Ms, Fishbone, Mann Kendall Trending, and Control charting Poisson and Negative Binomial distributions; Providing quality guidance in handling nonconformances related to the medical device development process, including investigations for root cause using 5 Whys, 5Ms, and Fault Tree Analysis tools; Providing quality and technical support for the evaluation of change assessments for the combination product Quality system; Evaluating the suitability of test methods and equipment for verification testing, including developing riskbased validation planning Installation Qualifications and Operation Qualifications, Precision and Accuracy management under general fit for use type performance testing; Developing suitable riskbased sampling plans for design verification and validation testing and leading relevant risk assessment and control planning activities; and Using Geometric, Dimensioning, and Tolerancing principles including Maximum and Least Material requirements, Stacked Tolerance chains, and PositionalVectorStatistical Tolerancing.br br Alternatively, the employer will accept a Masters degree or foreign equivalent in a stated field plus eight 8 years of experience. Any suitable combination of education, training or experience is acceptable.

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

2022-07-13

SWA Job Order End Date

2022-08-18

Sunday Edition Newspaper

Y

First Newspaper Name

The Washington Post

First Advertisement Start Date

2022-08-14

Second Newspaper Ad Name

The Washington Post

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-08-21

Employer Website From Date

2022-08-02

Employer Website To Date

2022-10-26

Professional Organization Ad From Date

2024-01-01 00:02:09

Professional Organization Advertisement To Date

2024-01-01 00:02:09

Job Search Website From Date

2022-08-14

Job Search Website To Date

2022-08-28

Employee Referral Program From Date

2022-07-27

Employee Referral Program To Date

2022-08-15

Local Ethnic Paper From Date

2022-08-17

Local Ethnic Paper To Date

2022-08-17

Radio/TV Ad From Date

2024-01-01 00:02:09

Radio/TV Ad To Date

2024-01-01 00:02:09

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

Foreign Worker Years of Education Completed

2007

Foreign Worker Institution of Education

UNIVERSITY OF MASSACHUSETTS

Foreign Worker Education Institution Address 1

220 PAWTUCKET ST

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

LOWELL

Foreign Worker Education Institution State/Province

MA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

1854

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Hyla K Rosenberg

Preparer Title

Partner

Preparer Email

svialva@fragomen.com

Employer Information Declaration Name

Adriana Echeverri

Employer Information Declaration Title

International Experiences, Regional Lead NA