Fiscal Year

2022

Case Number

A-19242-51785

Case Status

Certified-Expired

Received Date

2021-06-18

Decision Date

2022-03-16

Refile

N

Original File Date

2022-01-01 11:05:44

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

Merit Medical Systems, Inc.

Employer Name Slug

merit-medical-systems-inc

Employer Address 1

1600 Merit Parkway

Employer Address 2

Employer City

South Jordan, UT

Employer City Slug

south-jordan-ut

Employer State

UTAH

Employer State Slug

utah

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

84095

Employer Phone

8012531600

Employer Number of Employees

2997

Employer Year Commenced Business

1987

NAICS Code

339112

FW Ownership Interest

N

Employer Contact Name

Richard Portrey

Employer Contact Address 1

1600 Merit Parkway

Employer Contact Address 2

Employer Contact City

South Jordan, UT

Employer Contact State/Province

UTAH

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

84095

Employer Contact Phone

8012531600

Employer Contact Email

rportrey@merit.com

Agent Attorney Name

Arnold G Gardner

Agent Attorney Firm Name

Gardner and Taylor, PLLC

Agent Attorney Phone

(801) 468-1400

Agent Attorney Address 1

2257 S 1100 E

Agent Attorney Address 2

Suite 201

Agent Attorney City

Salt Lake City

Agent Attorney State/Province

UTAH

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

84106

Agent Attorney Email

agg@gardnerandtaylor.com

PW Track Number

P10020163645633

PW SOC Code

11-1021

PW SOC Title

General and Operations Managers

PW Skill Level

Level IV

PW Wage

178693.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2020-10-06

PW Expiration Date

2021-06-30

Wage Offer From

178693.00

Wage Offer To

0.00

Average Salary

178693.00

Wage Unit of Pay

Year

Worksite Address 1

1711 Quiet Trail Drive

Worksite Address 2

Worksite City

Chula Vista

Worksite City Slug

chula-vista

Worksite State

CALIFORNIA

Worksite Postal Code

91915

Job Title

Senior Director Quality Assurance, Latin America

Job Title Slug

senior-director-quality-assurance-latin-america

Minimum Education

Bachelor's

Major Field of Study

Industrial Engineering

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

Y

Accept Alternative Major Field of Study

Quality Engineering, Materials Engineering, Biomedical Engineering or 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

120

Accept Alternative Job Title

Quality Assurance Manager, Regulatory Affairs Manager, Engineering Manager, or closely related field

Job Opportunity Requirements Normal

Y

Foreign Language Required

Y

Specific Skills

Ten years experience as a Quality Assurance Manager, Regulatory Affairs Manager, Engineering Manager, or closely related field, must include 4 years based in Latin America performing direct regional support;br Demonstrable knowledge of and prior experience in the startup of manufacturing distribution operations in Latin America;br Ability to speak and write universitylevel Spanish and English;br Demonstrable knowledge of and prior experience in performing statistical analysis techniques, including hypothesis testing, types of distributions, and confidence intervals;br Prior experience as a Quality Manager in medical device product manufacturing and in the development of cardiovascular and vascular access devices within Latin and North America;br Demonstrable knowledge of and prior experience with FDA Medical Device Regulations, including 21 CFR 820, 21 CFR 801, and 21 CFR 807 US; ANVISA RDC 162013 Technical Regulation of Good Manufacturing Practices of Medical Devices and In Vitro Diagnostic Devices Brazil; NOM241SSA12012, Buenas prcticas de fabricacin para establecimientos dedicados a la fabricacin de dispositivos medicos Mexico; Medical Devices Directive 9342EEC; ISO 13485 Quality System Standard; ISO 14971 Risk Management; Canadian Medical Device Regulation CMDR Canada; and PMDA Pharmaceuticals Medical Devices Act MO #169 Ministerial Ordinance No. 169 Japan;br Demonstrable knowledge of and prior experience in ISO, ASTM biomedical testing standards and Farmacopea de los Estados Unidos Mexicanos, Suplemento de Dispositivos Medicos biomedical testing standards;br Demonstrable experience in manufacturing processes implementation in Latin American Countries;br Demonstrable experience certifying clean rooms to international standards as well to specific requirements defined in Mexican regulation NOM241SSA12012;br Prior experience in leading organizations through external inspections and audits, including FDA, COFEPRIS, Notified Bodies, Competent Authorities, Regulatory Agencies and Customersbr Demonstrable knowledge of and experience in the implementation of Quality Systems for Distribution centers in Latin American countries including Suplemento para Establecimientos dedicado a la venta y dems insumos para la salud en Mexico.br Travel Requirements Travel to Merit Medical Systems, Inc. head office in South Jordan, UT at a minimum 1 time per month for periods of up to 5 days per trip. Travel to Merit Medical Systems, Inc. facility in Tijuana, Mexico 2 times per month for periods up to 5 days per trip. Travel to Merit Medical Systems, Inc. facilities in So Paulo, Brazil, and Joinville, Brazil at a minimum of 2 times per year, for up to 5 days per trip. Other travel to internal and external suppliers on as needed basis.

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

2020-12-20

SWA Job Order End Date

2021-03-04

Sunday Edition Newspaper

Y

First Newspaper Name

The San Diego UnionTribune

First Advertisement Start Date

2021-01-10

Second Newspaper Ad Name

The San Diego UnionTribune

Second Advertisement Type

Newspaper

Second Ad Start Date

2021-01-17

Employer Website From Date

2020-12-21

Employer Website To Date

2021-01-14

Professional Organization Ad From Date

2022-01-01 11:05:44

Professional Organization Advertisement To Date

2022-01-01 11:05:44

Job Search Website From Date

2021-05-05

Job Search Website To Date

2021-06-15

Employee Referral Program From Date

2022-01-01 11:05:44

Employee Referral Program To Date

2022-01-01 11:05:44

Local Ethnic Paper From Date

2021-01-11

Local Ethnic Paper To Date

2021-01-18

Radio/TV Ad From Date

2022-01-01 11:05:44

Radio/TV Ad To Date

2022-01-01 11:05:44

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

H-1B

Foreign Worker Education

Bachelor's

Foreign Worker Information: Major

INDUSTRIAL ENGINEERING

Foreign Worker Years of Education Completed

1998

Foreign Worker Institution of Education

INSTITUTO TECNOLOGICO DE CHIHUAHUA II

Foreign Worker Education Institution Address 1

Foreign Worker Education Institution Address 2

AV TECNOLOGICO 2909

Foreign Worker Education Institution City

CHIHUAHUA

Foreign Worker Education Institution State/Province

CHIHUAHUA

Foreign Worker Education Institution Country

MEXICO

Foreign Worker Education Institution Postal Code

31310

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Arnold G Gardner

Preparer Title

Attorney

Preparer Email

agg@gardnerandtaylor.com

Employer Information Declaration Name

Richard W Portrey

Employer Information Declaration Title

Director, Employment Recruiting