Fiscal Year

2024

Case Number

A-22263-24444

Case Status

Certified-Expired

Received Date

2022-10-20

Decision Date

2023-10-02

Refile

N

Original File Date

2024-01-01 00:00:20

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

INTERSECT ENT

Employer Name Slug

intersect-ent

Employer Address 1

1555 ADAMS DRIVE

Employer Address 2

Employer City

MENLO PARK

Employer City Slug

menlo-park

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

94025

Employer Phone

650-788-7947

Employer Number of Employees

189

Employer Year Commenced Business

2006

NAICS Code

339113

FW Ownership Interest

N

Employer Contact Name

Cate McCarrell

Employer Contact Address 1

1555 Adams Drive

Employer Contact Address 2

Employer Contact City

Menlo Park

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

94025

Employer Contact Phone

650-788-7947

Employer Contact Email

lisa.marie.pedrys@medtronic.com

Agent Attorney Name

James Pack

Agent Attorney Firm Name

Fragomen, Del Rey, Bernsen Loewy, LLP

Agent Attorney Phone

9492610209

Agent Attorney Address 1

18401 Von Karman Avenue

Agent Attorney Address 2

Suite 255

Agent Attorney City

Irvine

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

92612

Agent Attorney Email

dallert@fragomen.com

PW Track Number

P10021281635109

PW SOC Code

11-3051.01

PW SOC Title

Quality Control Systems Managers

PW Skill Level

Level II

PW Wage

123261.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-04-07

PW Expiration Date

2022-07-06

Wage Offer From

149344.00

Wage Offer To

0.00

Average Salary

149344.00

Wage Unit of Pay

Year

Worksite Address 1

1555 ADAMS DRIVE

Worksite Address 2

Worksite City

Menlo Park

Worksite City Slug

menlo-park

Worksite State

CALIFORNIA

Worksite Postal Code

94025

Job Title

Manager, Quality Systems & Compliance

Job Title Slug

manager-quality-systems-compliance

Minimum Education

Master's

Major Field of Study

LIFE SCIENCES, CHEMISTRY, ENGINEERING

Required Training

N

Required Experience

Y

Required Experience Months

24

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

OR A CLOSELY RELATED FIELD

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

in Medical Device andor Pharmaceutical Industry

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

This position requires a Masters degree or foreign equivalent in Life Sciences, Chemistry, Engineering, or in a closely related field, plus 2 years of work experience in Medical Device andor Pharmaceutical Industry.br br REQUIRED EXPERTISEKNOWLEDGE 1. Ensure compliance of products with combination drugdevice regulations and guidance from Food and Drug Administration FDA 2. Supporting production and design quality in medical device or pharmaceutical industries. 3. Working on all phases of Corrective and Preventive Actions CAPA including investigation, action, effectiveness, and closure. 4. Ensure compliance of quality system procedures with applicable risk management standards, and quality system regulations from Food and Drug Administration FDA and International Organization for Standardization ISO. 5. Conducting postmarket monitoring of medical devices or pharmaceuticals, including Medical Device Reports MDR, Complaint Handling, Risk Management, and Recall.br br MUST POSSESS EXPERTISE KNOWLEDGE SUFFICIENT TO ADEQUATELY PERFORM THE DUTIES OF THE JOB BEING OFFERED. EXPERTISE KNOWLEDGE MAY BE GAINED THROUGH EMPLOYMENT EXPERIENCE OR EDUCATION. SUCH EXPERTISE KNOWLEDGE CANNOT BE quot;QUANTIFIEDquot; BY quot;TIME.quot;br br Telecommuting Permitted.

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

2022-07-17

SWA Job Order End Date

2022-08-19

Sunday Edition Newspaper

Y

First Newspaper Name

San Francisco Chronicle

First Advertisement Start Date

2022-07-24

Second Newspaper Ad Name

San Francisco Chronicle

Second Advertisement Type

Newspaper

Second Ad Start Date

2022-07-31

Employer Website From Date

2024-01-01 00:00:20

Employer Website To Date

2024-01-01 00:00:20

Professional Organization Ad From Date

2024-01-01 00:00:20

Professional Organization Advertisement To Date

2024-01-01 00:00:20

Job Search Website From Date

2022-07-28

Job Search Website To Date

2022-08-03

Employee Referral Program From Date

2022-06-30

Employee Referral Program To Date

2022-09-19

Local Ethnic Paper From Date

2022-07-27

Local Ethnic Paper To Date

2022-07-27

Radio/TV Ad From Date

2024-01-01 00:00:20

Radio/TV Ad To Date

2024-01-01 00:00:20

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

BIOMEDICAL ENGINEERING

Foreign Worker Years of Education Completed

2015

Foreign Worker Institution of Education

UNIVERSITY OF SOUTHERN CALIFORNIA

Foreign Worker Education Institution Address 1

3650 MCCLINTOCK AVE

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

LOS ANGELES

Foreign Worker Education Institution State/Province

CA

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

90089

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

James Y Pack

Preparer Title

Partner

Preparer Email

JPack@Fragomen.com

Employer Information Declaration Name

Lisa Pedrys

Employer Information Declaration Title

Director