Previous State Work Force Agency (SWA) Case Number Stete:
Schedule A or a Sheepherder Occupation :N
Company Info
Employer Name:Merit Medical Systems, Inc.
Employer Address_Line 1:1600 Merit Parkway
Employer Address_Line 2:
Employer City :South Jordan, UT
State:
Employer State/ Province:UTAH
Employer Country:UNITED STATES OF AMERICA
Employer Postal Code:84095
Employer Phone No.:8012531600
Employer Phone Extent No.:
Total Number of Employees:2997
Employer Year of Commenced :
NAICS Code:339112
Foreign Worker Ownership & Interest:N
HR Info
Employer Contact Name:Richard Portrey
Employer Contact Address Line1:1600 Merit Parkway
Employer Contact Address Line2:
Employer Contact City:South Jordan, UT
Employer Contact State/ Provice:UTAH
Employer Contact Country :UNITED STATES OF AMERICA
Employer Contact Post Code:84095
Employer Contact Phone:8012531600
Employer Contact Email:rportrey@merit.com
Attorney
Agent/ Attorney Name:Arnold G Gardner
Agent/ Attorney Firm Name:Gardner and Taylor, PLLC
Agent/ Attorney Phone:(801) 468-1400
Agent/ Attorney Phone Ext.:
Agent/ Attorney Address Line 1:2257 S 1100 E
Agent/ Attorney Address Line 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
Position Info
Prevailing Wage Track Number:P10020163645633
Prevailing Wage SOC Code :11-1021
Prevailing Wage SOC Title :General and Operations Managers
Prevailing Wage Skill Level:Level IV
Prevailing Wage:178693
Prevailing Wage Unit of Pay:Year
Prevailing Wage Source:OES
Prevailing Wage Other Source:
Prevailing Wage Determination Date :2020-10-06
Prevailing Wage Expiration Date :2021-06-30
Wage Offer From:178693
Wage Offer To:
Wage Offer Unit of Pay:Year
Workstie Address Line 1:1711 Quiet Trail Drive
Worksite Address Line 2:
Worksite City :Chula Vista
Worksite State:CALIFORNIA
Worksite Postal Code:91915
Job Title:Senior Director Quality Assurance, Latin America
Minimum Education:Bachelor's
Other Degree/ Diploma:
Major Field of Study:Industrial Engineering
Required Training:N
Required Training Month:
Required Field of Training:
Required Experience :N
Required Expreience Months :
Accept Alternate Field of Study:Y
Accept Alternate Major:Quality Engineering, Materials Engineering, Biomedical Engineering or closely related field.
Alternate Combination of Education/ Experience:N
Required Alternate Level of Education :
Other Alternate Level of Education:
Acceptable Years of Experience:
Accept Foreign Educationa:Y
Acceptable Alternate Occupation:Y
Acceptable Alternate Occupation Month:120
Accept Alternate Job Title:Quality Assurance Manager, Regulatory Affairs Manager, Engineering Manager, or closely related field
Normal Requirements of Job Opportunity:Y
Required Foreign Language: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 Applied Foreign Worker:Y
ForeignWorker Live on Premises :N
Live in Domestic Service Worker:N
Employment Contract :
Professional Occupation :Y
College/ University Teacher:N
Competitive Process:
Basic Recruitment Process :
Teacher Select Date:
Teacher Publish Journal Name:
Additional Recruitment Information:
Job Oder Start Date:2020-12-20
Job Oder 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 Name:The San Diego UnionTribune
Second Advertisement Type:Newspaper
Second Ad Start Date:2021-01-17
Job Fair From Date:
Job Fair to Date:
On Campus Recruiting from Date:
On Campus Recruiting to Date:
Employer Website from Date:2020-12-21
Employer Website to Date:2021-01-14
Pro. Org. Ad from Date:
Pro.Org. Ad to Date:
Job Search Website from Date:2021-05-05
Job Search Website to Date:2021-06-15
Private Employment Firm from Date:
Pricate Employment Firm to Date:
Employee Referral Program from Date:
Employee Referral Program to Date:
Campus Placement from Date:
Campus Placement to Date:
Local Ethnic Newspaper from Date:2021-01-11
Local Ethnic Newspaper to Date:2021-01-18
Radio/TV Ad from Date:
Radio/TV Ad to Date:
Employer Received the Payment:N
Payment Details:
Bargaining Representative Notified:N/A
Posted Notice at Worksite:Y
Layoff in Past Six Months:N
US Worker Considered:
Country of Citizenship:MEXICO
Foreign Worker Birth Country:MEXICO
Class of Admission :H-1B
Employee Info
Foreign Worker Education:Bachelor's
Foreign Worker Education Other:
Foreign Worker Major:INDUSTRIAL ENGINEERING
Year of Compelted Education:1998
Foreign Worker Istitution of Eduation:INSTITUTO TECNOLOGICO DE CHIHUAHUA II
Foreign Worker Education Instution Address Line 1:
Foreign Worker Education Institution Address Line 2:AV TECNOLOGICO 2909
