Fiscal Year

2024

Case Number

A-22297-44382

Case Status

Certified-Expired

Received Date

2022-12-19

Decision Date

2023-11-16

Refile

N

Original File Date

2024-01-01 00:18:38

Previous SWA Case Number State

Schedule A Sheepherder

N

Employer Name

NeoCoil, LLC

Employer Name Slug

neocoil-llc

Employer Address 1

N27 W23910A Paul Rd

Employer Address 2

Suite A

Employer City

Pewaukee

Employer City Slug

pewaukee

Employer State

WISCONSIN

Employer State Slug

wisconsin

Employer Country

UNITED STATES OF AMERICA

Employer Postal Code

53072

Employer Phone

262-347-1250

Employer Number of Employees

85

Employer Year Commenced Business

2005

NAICS Code

334510

FW Ownership Interest

N

Employer Contact Name

Elizabeth Cieminski

Employer Contact Address 1

N27 W23910A Paul Rd

Employer Contact Address 2

Suite A

Employer Contact City

Pewaukee

Employer Contact State/Province

WISCONSIN

Employer Contact Country

UNITED STATES OF AMERICA

Employer Contact Postal Code

53072

Employer Contact Phone

262-522-6351

Employer Contact Email

liz.cieminski@neocoil.com

Agent Attorney Name

Alberto Martinez

Agent Attorney Firm Name

Fragomen, Del Rey, Bernsen Loewy LLP

Agent Attorney Phone

3122636101

Agent Attorney Address 1

333 W. Wacker Dr.

Agent Attorney Address 2

15th Floor

Agent Attorney City

Chicago

Agent Attorney State/Province

ILLINOIS

Agent Attorney Country

UNITED STATES OF AMERICA

Agent Attorney Postal Code

60606

Agent Attorney Email

chicagoebu@fragomen.com

PW Track Number

P10021362789062

PW SOC Code

17-2199

PW SOC Title

Validation Engineers

PW Skill Level

Level IV

PW Wage

102586.00

PW Unit of Pay

Year

PW Wage Source

OES

PW Determination Date

2022-06-24

PW Expiration Date

2022-09-22

Wage Offer From

102586.00

Wage Offer To

0.00

Average Salary

102586.00

Wage Unit of Pay

Year

Worksite Address 1

N27 W23910A Paul Rd

Worksite Address 2

Worksite City

Pewaukee

Worksite City Slug

pewaukee

Worksite State

WISCONSIN

Worksite Postal Code

53072

Job Title

Sr. Quality Systems & Regulatory Specialist

Job Title Slug

sr-quality-systems-regulatory-specialist

Minimum Education

Bachelor's

Major Field of Study

Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field.

Required Training

N

Required Experience

N

Required Experience Months

Accept Alternative Field of Study

N

Accept Alternative Major Field of Study

Accept Alternative Combination

Y

Accept Alternative Combination Education

Associate's

Accept Alternative Combination Education Years

15

Accept Foreign Education

Y

Accept Alternative Occupation

Y

Accept Alternative Occupation Months

120

Accept Alternative Job Title

Qlty Sys or Regltry exp in med dvce indsty or rltd fld tht is fed or intrnationlly regltd

Job Opportunity Requirements Normal

N

Foreign Language Required

N

Specific Skills

Education Requirement This position requires a Bachelor of Science degree, or foreign equivalent, in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field.br br Work Experience Requirement 10 years Quality Systems andor Regulatory experience in the medical device industry or another related field that is federally andor internationally regulated.br br Alternatively, the employer will accept Associates with 15 years of experience in the medical device industry or other related field that is federally andor internationally regulated.br br Specific Skills Requirement Additionally, the applicant must have professional experience with 1 Working knowledge of international medical device standards and regulations e.g., ISO 13485, ISO 10993x, IEC 60601x, U.S FDA 21 CFR 820, MDSAP, EU MDR, etc.; 2 Interprets and assesses regulatory requirements for applicability to applicable products and quality system processes andor liaise with external regulatory resourcesservices; 3 Communicates with international regulatory entities and customers regarding licensing inquiries, product registrations, import export regulations; 4 Supporting external audits and regulatory inspections; 5 Supporting new product development teams by establishing product regulatory strategy for applicable markets; 6 Applies a riskbased approach in providing options and regulatory recommendations for engineering changes throughout the product lifecycle; 7 Preparing initial product registrations and submissions, device listings, and applicable renewals when required; 8 Reviewing and approves product labeling and product literature for compliance with applicable international standards and regulations; 9 Maintains documentation needed to support regulated product throughout the products lifecycle, including but not limited to, technical file maintenance, recall coordination and medical device reporting; 10 Supports creation and maintenance of technical documentation and Declarations of Conformity in support of international product registrations e.g., CE marking of conformity; 11 Establishes and manages corrective and preventive actions CAPA systems and processes, acts as CAPA Review Board Chair CRB, clinical evaluations and literature searches; 12 Implements corrective and preventive actions, and corrections, as necessary to address nonconformities and prevent their recurrence. Mentors less experienced staff on the appropriate CAPA methodologies; 13 Manages the internal audit program, as required, to determine QMS effectiveness and to ensure compliance with the established regulatory requirements. Acts as lead internal auditor; 14 Participates in Quality Planning; leads Quality Planning meetings; and 15 Supports preparation for and participate in Clinical Evaluations, Management Reviews, External Audits and other duties as assigned.

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

2022-09-14

SWA Job Order End Date

2022-10-17

Sunday Edition Newspaper

Y

First Newspaper Name

MILWAUKEE JOURNAL SENTINEL

First Advertisement Start Date

2022-10-02

Second Newspaper Ad Name

MILWAUKEE JOURNAL SENTINEL

Second Advertisement Type

Journal

Second Ad Start Date

2022-10-09

Employer Website From Date

2022-09-19

Employer Website To Date

2022-10-04

Professional Organization Ad From Date

2024-01-01 00:18:38

Professional Organization Advertisement To Date

2024-01-01 00:18:38

Job Search Website From Date

2022-09-26

Job Search Website To Date

2022-10-10

Employee Referral Program From Date

2022-09-15

Employee Referral Program To Date

2022-09-30

Local Ethnic Paper From Date

2024-01-01 00:18:38

Local Ethnic Paper To Date

2024-01-01 00:18:38

Radio/TV Ad From Date

2024-01-01 00:18:38

Radio/TV Ad To Date

2024-01-01 00:18:38

Employer Received Payment

N

Posted Notice at Worksite

Y

Layoff in Past Six Months

N

Country of Citizenship

CHINA

Foreign Worker Birth Country

CHINA

Class of Admission

H-1B

Foreign Worker Education

Bachelor's

Foreign Worker Information: Major

BIOMEDICAL ENGINEERING

Foreign Worker Years of Education Completed

2002

Foreign Worker Institution of Education

CAPITAL MEDICAL UNIVERSITY

Foreign Worker Education Institution Address 1

NO.10, YOU AN MENG

Foreign Worker Education Institution Address 2

Foreign Worker Education Institution City

BEIJING

Foreign Worker Education Institution State/Province

Foreign Worker Education Institution Country

CHINA

Foreign Worker Education Institution Postal Code

100069

Foreign Worker Experience with Employer

N

Foreign Worker Employer Pays for Education

N

Foreign Worker Currently Employed

Y

Employer Completed Application

N

Preparer Name

Alberto Martinez

Preparer Title

Attorney

Preparer Email

Chicagoebu@fragomen.com

Employer Information Declaration Name

Liz Cieminski

Employer Information Declaration Title

HR Generalist