Fiscal Year

2022

Case Number

A-21287-58505

Case Status

Certified

Received Date

2021-12-22

Decision Date

2022-08-04

Refile

N

Original File Date

2022-01-01 11:49:24

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

VERB SURGICAL INC.

Employer Name Slug

verb-surgical-inc

Employer Address 1

5490 GREAT AMERICA PARKWAY

Employer Address 2

Employer City

SANTA CLARA

Employer City Slug

santa-clara

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

95054

Employer Phone

7325245931

Employer Number of Employees

132000

Employer Year Commenced Business

2015

NAICS Code

334510

FW Ownership Interest

N

Employer Contact Name

James Kim

Employer Contact Address 1

501 George Street

Employer Contact Address 2

Employer Contact City

New Brunswick

Employer Contact State/Province

NEW JERSEY

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

8933

Employer Contact Phone

7325245931

Employer Contact Email

jkim43@its.jnj.com

Agent Attorney Name

KANE VONGSAVANH

Agent Attorney Firm Name

Berry Appleman Leiden LLP

Agent Attorney Phone

4695052272

Agent Attorney Address 1

8300 Greensboro Drive

Agent Attorney Address 2

Suite 550

Agent Attorney City

McLean

Agent Attorney State/Province

VIRGINIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

22102

Agent Attorney Email

kvongsavanh@bal.com

PW Track Number

P10020338936789

PW SOC Code

15-1121

PW SOC Title

Computer Systems Analysts

PW Skill Level

Level IV

PW Wage

144414.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2021-05-07

PW Expiration Date

2021-08-05

Wage Offer From

172000.00

Wage Offer To

182000.00

Average Salary

177000.00

Wage Unit of Pay

Year

Worksite Address 1

5490 Great America Pkwy

Worksite Address 2

Worksite City

Santa Clara

Worksite City Slug

santa-clara

Worksite State

CALIFORNIA

Worksite Postal Code

95054

Job Title

Senior Quality Validation Manager

Job Title Slug

senior-quality-validation-manager

Minimum Education

Bachelor's

Major Field of Study

See H.14

Required Training

N

Required Experience

Y

Required Experience Months

60

Accept Alternative Field of Study

Y

Accept Alternative Major 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

60

Accept Alternative Job Title

SeeH.14

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

EMPLOYER WILL ACCEPT BACHELORS DEGREE IN CHEMISTRY, GENOMICS, MOLECULAR BIOLOGY, PHARMACYPHARMACEUTICAL ENGINEERING, COMPUTER SCIENCE, SOFTWARE ENGINEERING, OR RELATED FIELD, FOLLOWED BY FIVE YEARS OF PROGRESSIVE, POSTBACCALAUREATE WORK EXPERIENCE IN JOB OFFERED OR FIVE YEARS OF PROGRESSIVE, POSTBACCALAUREATE WORK EXPERIENCE IN A POSITIONRELATED OCCUPATION. POSITION REQUIRESbr br 5 YEARS OF EXPERIENCE LEADING VALIDATIONS OF VARIOUS TYPES OF SOFTWARE APPLICATIONS, INCLUDING WRITING AND REVIEWINGAPPROVING PROCESS DOCUMENTS SUCH AS SOPSWORK INSTRUCTIONS, COMPUTER VALIDATION DOCUMENTS IN A MEDICAL DEVICE, PHARMACEUTICAL, OR BIOLOGICS ENVIRONMENT IN THE AREAS OF QUALITY ASSURANCE, COMPLIANCE, INFORMATION TECHNOLOGY, AND MANUFACTURING; KNOWLEDGE OF FDA, EUROPEAN UNION, AND GXP REGULATORY REQUIREMENTS, INCLUDING 21 CFR PART 11ANNEX 11, ISO 1348514791, ICH Q9, FROM A GOVERNANCE, RISK, AND COMPLIANCE PERSPECTIVE. 5 YEARS; SDLC METHODOLOGIES, INCLUDING WATERFALL, VMODEL, AND, AGILE RISK BASED MODEL. 5 YEARS; VALIDATION EXPERIENCE WITH CONFIGURED OFFTHESHELF IN DIFFERENT ENVIRONMENTS SAAS, CLOUD HOSTED, AND ONPREMISE 5 YEARS; TECHNICAL EXPERIENCE IN INFRASTRUCTURE AND APPLICATIONS. 5 YEARS; EXPERIENCE IN IMPLEMENTATION AND CONTINUOUS IMPROVEMENT OF COMPUTER VALIDATION PROCESS ALIGNING WITH REGULATORY REQUIREMENTS AND INDUSTRY TRENDS; REGULATORY AND VENDOR AUDITS, QUALITY RISK MANAGEMENT TECHNIQUES AND TOOLS E.G. FMEA, SRA, ETC.; DATA GOVERNANCEINTEGRITYLIFE CYCLES AND MANAGEMENT; ORGANIZATIONAL, MANAGEMENT AND LEADERSHIP SKILLS; KNOWLEDGE AND EXPERIENCE IN QUALITY MANAGEMENT SYSTEMS E.G. CAPANCRDEVIATIONETC.; AND ABILITY TO TRAIN LARGE GROUPS ON COMPUTER VALIDATION PROCESSES.

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

2021-07-20

SWA Job Order End Date

2021-08-25

Sunday Edition Newspaper

Y

First Newspaper Name

Mercury News

First Advertisement Start Date

2021-07-25

Second Newspaper Ad Name

Mercury News

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-08-01

Employer Website From Date

2021-09-30

Employer Website To Date

2021-10-08

Professional Organization Ad From Date

2022-01-01 11:49:24

Professional Organization Advertisement To Date

2022-01-01 11:49:24

Job Search Website From Date

2021-07-19

Job Search Website To Date

2021-08-03

Employee Referral Program From Date

2022-01-01 11:49:24

Employee Referral Program To Date

2022-01-01 11:49:24

Local Ethnic Paper From Date

2021-07-30

Local Ethnic Paper To Date

2021-07-30

Radio/TV Ad From Date

2022-01-01 11:49:24

Radio/TV Ad To Date

2022-01-01 11:49:24

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

CHEMISTRY

Foreign Worker Years of Education Completed

2006

Foreign Worker Institution of Education

EASTERN NEW MEXICO UNIVERSITY

Foreign Worker Education Institution Address 1

1500 S AVENUE K

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

PORTALES

Foreign Worker Education Institution State/Province

NM

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

88130

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Kane Vongsavanh

Preparer Title

Sr. Associate

Preparer Email

kvongsavanh@bal.com

Employer Information Declaration Name

James Kim

Employer Information Declaration Title

Senior Manager, Global Immigration