Fiscal Year

2021

Case Number

A-20118-47727

Case Status

Certified-Expired

Received Date

2020-06-26

Decision Date

2021-01-12

Refile

N

Original File Date

2021-01-01 08:57:22

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

DEXCOM, INC.

Employer Name Slug

dexcom-inc

Employer Address 1

6340 SEQUENCE DRIVE

Employer Address 2

Employer City

SAN DIEGO

Employer City Slug

san-diego

Employer State

CALIFORNIA

Employer State Slug

california

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

92121

Employer Phone

(858) 875-9520

Employer Number of Employees

2609

Employer Year Commenced Business

1999

NAICS Code

334510

FW Ownership Interest

N

Employer Contact Name

Melia Nicole Kunde

Employer Contact Address 1

6310 Sequence Drive

Employer Contact Address 2

Employer Contact City

San Diego

Employer Contact State/Province

CALIFORNIA

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

92121

Employer Contact Phone

(858) 875-9761

Employer Contact Email

nicole.kunde@dexcom.com

Agent Attorney Name

Amanda M Mullane

Agent Attorney Firm Name

Larrabee Albi Coker LLP

Agent Attorney Phone

858-642-0420

Agent Attorney Address 1

Larrabee Albi Coker LLP

Agent Attorney Address 2

P.O. Box 919016

Agent Attorney City

San Diego

Agent Attorney State/Province

CALIFORNIA

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

92191-9016

Agent Attorney Email

amanda@larrabee.com

PW Track Number

P10019255056422

PW SOC Code

17-2112

PW SOC Title

Industrial Engineers

PW Skill Level

Level IV

PW Wage

112341.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-01-16

PW Expiration Date

2020-06-30

Wage Offer From

112341.00

Wage Offer To

0.00

Average Salary

112341.00

Wage Unit of Pay

Year

Worksite Address 1

6310 Sequence Drive

Worksite Address 2

Worksite City

San Diego

Worksite City Slug

san-diego

Worksite State

CALIFORNIA

Worksite Postal Code

92121

Job Title

Manager, Quality Assurance

Job Title Slug

manager-quality-assurance

Minimum Education

Bachelor's

Major Field of Study

* See H.14

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

96

Accept Alternative Job Title

See H.14

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

H.4 and H.4B Bachelors degree or equivalent in Sciences Physics, or Material Science, Engineering Industrial Engineering, Mechanical Engineering, Electrical Engineering, or Biomedical Engineering, or a related field.br br H.10A and H.10B 8 years of progressive experience in Quality Assurance or Compliance in a regulated industry, with 2 years in a management or lead role.br br H.12 The requirements for the position are normal for the employer and within the industry. Employer marked not normal in H.12 due to ONET Job ZoneSVP analysis only.br br Work experience to include 1 Three years of experience in quality assurance with in the medical device industry. 2 Working with Nonconforming Materials as addressed by a CAPA Corrective and Preventive Action. 3 Utilizing Quality Management System QMS as applied to medical devices. 4 Writing reports on CAPA phases including updates to the inputs provided to ensure compliance to the business processes, Product Investigations, and Project Summary. 5 Reviewing, updating and completing CAPA documentation, including writing CAPA procedure manuals for various departments. 6 Supporting product recall assessments through product investigation and assessment. 7 Analyzing and interpreting technical procedures, international standards and government regulations to include FDA 21 CFR 820, ISO 13485, and ISO 14971. 8 Training CAPA owners and teams on CAPA processes and procedures, phases, requirements for each phase, and Root Cause analysis tools used in the CAPA process. 9 Statistical analysis of data. 10 Assessing data for trends, summarizing data and presenting metrics.br br Any and all experience can be gained concurrently.br br Position requires 25 domestic travel; expenses paid by employer.br br Employer requires background checks.br br J.12 Industrial and Systems Engineering evaluated as the equivalent of U.S. Bachelor of Science degree in Industrial Engineering.

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

2020-02-25

SWA Job Order End Date

2020-03-27

Sunday Edition Newspaper

Y

First Newspaper Name

The San Diego UnionTribune

First Advertisement Start Date

2020-03-01

Second Newspaper Ad Name

The San Diego UnionTribune

Second Advertisement Type

Newspaper

Second Ad Start Date

2020-03-08

Employer Website From Date

2021-01-01 08:57:22

Employer Website To Date

2021-01-01 08:57:22

Professional Organization Ad From Date

2021-01-01 08:57:22

Professional Organization Advertisement To Date

2021-01-01 08:57:22

Job Search Website From Date

2020-03-01

Job Search Website To Date

2020-03-09

Employee Referral Program From Date

2021-01-01 08:57:22

Employee Referral Program To Date

2021-01-01 08:57:22

Local Ethnic Paper From Date

2020-03-06

Local Ethnic Paper To Date

2020-03-06

Radio/TV Ad From Date

2021-01-01 08:57:22

Radio/TV Ad To Date

2021-01-01 08:57:22

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

TN

Foreign Worker Education

Bachelor's

Foreign Worker Information: Major

SEE H.14

Foreign Worker Years of Education Completed

1996

Foreign Worker Institution of Education

INSTITUTO TECNOLOGICO Y DE ESTUDIOS SUPERIORES DE MONTERREY

Foreign Worker Education Institution Address 1

CAMPUS CIUDAD JUAREZ, BLVD. TOMAS FERNANDEZ CAMPOS NO. 8945

Foreign Worker Education Institution Address 2

PARQUE INDUSTRIAL ANTONIO J. BERMUDEZ

Foreign Worker Education Institution City

CIUDAD JUAREZ

Foreign Worker Education Institution State/Province

CHIHUAHUA

Foreign Worker Education Institution Country

MEXICO

Foreign Worker Education Institution Postal Code

32470

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Amanda M Mullane

Preparer Title

Partner Attorney at Law

Preparer Email

amanda@larrabee.com

Employer Information Declaration Name

Melia Nicole Kunde

Employer Information Declaration Title

Sr. Employee Relations Compliance Specialist