Fiscal Year

2020

Case Number

A-19211-37467

Case Status

Certified-Expired

Received Date

2019-08-07

Decision Date

2019-10-09

Refile

N

Original File Date

2020-01-01 07:45:10

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

CEQUR CORPORATION

Employer Name Slug

cequr-corporation

Employer Address 1

65 BOSTON POST RD WEST

Employer Address 2

SUITE 140

Employer City

MARLBOROUGH

Employer City Slug

marlborough

Employer State

MASSACHUSETTS

Employer State Slug

massachusetts

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

1752

Employer Phone

508-486-0010

Employer Number of Employees

22

Employer Year Commenced Business

2008

NAICS Code

33911

FW Ownership Interest

N

Employer Contact Name

Robert Farra

Employer Contact Address 1

734 Forest St.

Employer Contact Address 2

Suite 100

Employer Contact City

Marlboro

Employer Contact State/Province

MASSACHUSETTS

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

1752

Employer Contact Phone

5084860010

Employer Contact Email

robert.farra@cequr.com

Agent Attorney Name

Lori B Geisinger

Agent Attorney Firm Name

Outside GC LLC

Agent Attorney Phone

7812537150

Agent Attorney Address 1

Outside GC LLC

Agent Attorney Address 2

P.O. Box 482

Agent Attorney City

Sharon

Agent Attorney State/Province

MASSACHUSETTS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

2067

Agent Attorney Email

lgeisinger@outsidegc.com

PW Track Number

P10018305822319

PW SOC Code

17-2112

PW SOC Title

Industrial Engineers

PW Skill Level

Level IV

PW Wage

114483.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2019-03-08

PW Expiration Date

2019-06-30

Wage Offer From

115000.00

Wage Offer To

0.00

Average Salary

115000.00

Wage Unit of Pay

Year

Worksite Address 1

734 Forest St.

Worksite Address 2

Suite 100

Worksite City

Marlboro

Worksite City Slug

marlboro

Worksite State

MASSACHUSETTS

Worksite Postal Code

1752

Job Title

Senior Quality Engineer

Job Title Slug

senior-quality-engineer

Minimum Education

Bachelor's

Major Field of Study

Mechanical, Industrial or Manufacturing Engineering

Required Training

N

Required Experience

Y

Required Experience Months

72

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Master's

Accept Alternative Combination Education Years

4

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

72

Accept Alternative Job Title

Quality EngineeringQuality Assurance role in medical device or pharmaceutical manufacturing industr

Job Opportunity Requirements Normal

Y

Foreign Language Required

N

Specific Skills

Sr. Quality Engineer must have BS in Mechanical, Industrial or Manufacturing Engineering or its foreign equiv, plus 6 yrs exp in Quality EngineeringQA role in medical device or pharmaceutical manufacturing industry; OR MS in Mechanical, Industrial or Manufacturing Engineering, plus 4 yrs exp in a Quality EngineeringQA role in medical device or pharmaceutical manufacturing industry. In addn or exp must include, Sr. Quality Engineer must have Prior exp in product development projects in medical device industry; Exp with 510k submissions andor FDA inspections; Excellent knowledge of risk management per ISO 14971; Strong knowledge of MS Office Suite statistical sampling analysis toolsmethods including Minitab; Six Sigma Green Belt or Black Belt Certification; Excellent organizational, verbal written communication skills. ANY SUITABLE COMBINATION OF EDUCATION, TRAINING, OR EXPERIENCE IS ACCEPTABLE.br br ADDL RESPONSE TO H. 12 CeQur is developing, manufacturing commercializing advanced yet simpletouse insulin delivery devices that make it easier for people living with type 2 diabetes to adhere to therapy and stay in control of their disease. CeQurs fully optimized device, PAQ, is a 3day, wearable device that provides freedom from multiple daily insulin injections. The DOLs ONET Online Classification for the position is 172112, Industrial Engineers, which typically design, develop, test evaluate integrated systems for managing industrial production processes, including human work factors, quality control, inventory control, logistics and material flow, cost analysis production coordination. The DOL classifies Industrial Engineers as a Job Zone 4 SVP range of 7lt;8 occupation, which normally requires a BS several yrs of exp. Sr. Quality Engineer at CeQur must have BS in Mechanical, Industrial or Manufacturing Engineering, plus 6 yrs exp, or MS in Mechanical, Industrial or Manufacturing Engineering, plus 4 yrs exp. Although the requirements exceed the normal reqs for Industrial Engineers, it is required in this case due to the seniority of the role and its sophisticated technical responsibilities.br br Moreover, CeQurs addl exp, knowledge skill reqs for the Sr. Quality Engineer position are normal for an Industrial Engineer role. Some of the reqs are core to the tasksknowledge listed on ONET, such as strong knowledge of MS Office Suite statistical sampling analysis toolsmethods including Minitab, and excellent organizational, verbal written communication skills. However, other reqs for the role are not explicitly listed on ONET, but are essential for the position at CeQur due to the nature of CeQurs business as a medical device manufacturer. For ex, prior exp in product development projects in medical device industry is essential for the Sr. Quality Engineer as a member of the Product Development team verifying all aspects of Design Control for the PAQ device. Six Sigma Green Belt or Black Belt Certification is critical because it is a set of techniques tools for process improvement. Also, 510k is a premarket FDA submission required to demonstrate that the medical device to be marketed is at least as safe and effective as substantially equivalent to a legally marketed device, and a Sr. Quality Engineer must have prior experience with 510k submissions andor FDA inspections in order to support 510K filings for new products in a reasonable manner. ISO International Organization for Standardization 14971 is an ISO standard for the application of risk management to medical devices, and ensures protective measures in the medical device or in the manufacturing process. It is essential for a Sr. Quality Engineer to have excellent knowledge of risk management per ISO 14971 to ensure that CeQurs projects are in compliance with GMP, QSR, ISO or other applicable requirements, and to participate in FDA inspections and ISO Certification.

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

2019-04-09

SWA Job Order End Date

2019-05-10

Sunday Edition Newspaper

Y

First Newspaper Name

The Boston Globe

First Advertisement Start Date

2019-04-14

Second Newspaper Ad Name

The Boston Globe

Second Advertisement Type

Newspaper

Second Ad Start Date

2019-04-21

Employer Website From Date

2019-04-09

Employer Website To Date

2019-05-10

Professional Organization Ad From Date

2020-01-01 07:45:10

Professional Organization Advertisement To Date

2020-01-01 07:45:10

Job Search Website From Date

2019-04-09

Job Search Website To Date

2019-05-10

Employee Referral Program From Date

2020-01-01 07:45:10

Employee Referral Program To Date

2020-01-01 07:45:10

Local Ethnic Paper From Date

2020-01-01 07:45:10

Local Ethnic Paper To Date

2020-01-01 07:45:10

Radio/TV Ad From Date

2020-01-01 07:45:10

Radio/TV Ad To Date

2020-01-01 07:45:10

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

INDUSTRIAL ENGINEERING AND MANAGEMENT

Foreign Worker Years of Education Completed

2013

Foreign Worker Institution of Education

OKLAHOMA STATE UNIVERSITY

Foreign Worker Education Institution Address 1

CO OSU GRADUATE COLLEGE

Foreign Worker Education Institution Address 2

202 WHITEHURST

Foreign Worker Education Institution City

STILLWATER

Foreign Worker Education Institution State/Province

OK

Foreign Worker Education Institution Country

UNITED STATES OF AMERICA

Foreign Worker Education Institution Postal Code

74078

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Lori B Geisinger

Preparer Title

Attorney

Preparer Email

lgeisinger@outsidegc.com

Employer Information Declaration Name

Robert Farra

Employer Information Declaration Title

CTO