Regulatory Affairs/Quality Assurance Engineer- H1-B Sponsorship Available - Hicksville, United States - Genadyne Biotechnologies

Genadyne Biotechnologies Hicksville, United States

5 days ago

Description

Job description

Regulatory Affairs/Quality Assurance Engineer - H1-B Sponsorship Available

Position Description:

Seeking a motivated, intelligent and hard-working individual to Develop and maintain quality and regulatory compliance in Genadyne' processes. Individual will ensure compliance with ISO 13485 and MDSAP requirements are maintained.

Specific Responsibilities:

Ensure the quality and processes are practiced and maintained.

Compile documents required for audits.

Create and maintain product technical files.

Initiate corrective and preventive actions for non-conformities.

Maintain/calibrate the accuracy of all testing equipment.

Conduct risk assessments of medical devices and processes.

Maintaining the effectiveness of quality control system and non-conforming materials control system.

Discuss and solve quality problems with vendors.

Investigate problems and make improvement on current processes.

Develop/design effective test methods.

Facilitate software design and development for medical devices.

Performance testing and reporting on software, hardware and the compatibility for all accessories.

Perform risk assessments for medical devices and accessories.

Development and prototyping of new products with existing or new vendors.

Abilities:

Familiar with FDA CFR 820, ISO 134850, SOPs regulations.

Extreme attention to details.

Ability to think outside the box with excellent problem solving abilities.

Excellent interpersonal, communication, and writing skills.

Highly organized.

Excellent computational skills.

Knowledge of European regulations is a plus.

Knowledge of common medical materials (silicone, polyurethane, etc.)

Knowledge of electrical circuits and basic programming.

Knowledge of C/C++ is a plus.

Experiences:

Regulatory compliance.

Quality management.

Cross functional team management.

Quality assurance

FDA regulations: 1 year (Preferred)

Requirements:

Bachelor degree in mechanical, electrical, material, biomedical engineering or relative field. (Master degree preferred.)

Salary Range:

$65, ,000/Annual

Job Type:

Full-time

Benefits:

Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Sick Time Off
Vacation Time Off

Schedule:

8 hour shift - In Person
Monday - Friday (9:00 am - 5:30 pm)

Veterinarian - Sponsorship Available

1 week ago

CH Recruitment Solutions Westport, United States

Job description · **Sponsorship Opportunity Available w/ Certain Degrees** · Applicants graduating from a veterinarian education program located outside of the United must have graduated from a program that is acceptable to the Educational Commission of Foreign Medical Graduates. ...
Veterinarian (FT or PT) - Sponsorship Available

4 days ago

CH Recruitment Solutions Westport, United States

Job Description · Job DescriptionJob description · **Sponsorship Opportunity Available w/ Certain Degrees** · Applicants graduating from a veterinarian education program located outside of the United must have graduated from a program that is acceptable to the Educational Commiss ...
Purchasing/Planning Associates- H1 B Sponsorship Available

1 day ago

Genadyne Biotechnologies Bohemia, United States

Job Description · Job DescriptionJob descriptionPosition Description: Maintain proper inventory levels for all production assembly teams by coordinating orders & deliveries with all suppliers. · Primary Objective: To efficiently manage purchasing and inventory, minimizing the lik ...
Marketing Coordinator

4 days ago

The LiRo Group Syosset, United States

Overview: · Ranked among the nation's top Construction Managers by Engineering News-Record, LiRo-Hill provides integrated construction, design, and technology solutions for a broad range of public and private sector clients**. **We currently provide the opportunity for a hybrid/f ...
Proposal Manager

19 hours ago

The LiRo Group Syosset, United States

Overview: · Ranked among the nation's top Construction Managers by Engineering News-Record, LiRo-Hill provides integrated construction, design, and technology solutions for a broad range of public and private sector clients**. **We currently provide the opportunity for a hybrid/f ...
Brand Manager

1 day ago

Natural Organics Inc Melville, United States

**Join the NaturesPlus Family** · For nearly 50 years, NaturesPlus products have been the gold standard in natural vitamins and supplements. Our family of nearly 400 employees is committed to producing the finest, most effective formulations available. Each and every one of our e ...
Account Representative

1 week ago

Paul Roman - State Farm Agency Intern Glen Cove, United States

**Benefits**: · - Equipment Provided · - Licensing sponsorship · - Bonus based on performance · - Competitive salary · - Opportunity for advancement · - Paid time off · - Training & development · - Signing bonus · - Parental leave · **INTERN** **AGENCY DESCRIPTION**: · Are you ou ...
Inspectors (Nicet I, Ii)

1 week ago

The LiRo Group Commack, United States

Overview: · Ranked among the nation's top Construction Managers by Engineering News-Record, LiRo-Hill provides integrated construction, design, and technology solutions for a broad range of public and private sector clients**.** · Due to our continued growth, we are seeking **Ins ...
Accounting, Tax Staff

1 week ago

POSI New York, United States

**Overview**: · **Position: Accounting, tax and payroll outsourcing staff** · **Qualifications: Accounting, business major or accounting experience (new graduates welcome, experience preferred)** · **Location: New York(Hybrid)** · **Salary: Based on experience, ability, previous ...
Financial Sales Associate

1 day ago

Wall Street Consulting LLC Flushing, United States

Build and expand a client base by acquiring new clients on an ongoing basis. Offer knowledgeable and customized financial guidance to meet clients' specific needs. Maintain regular contact with clients to stay informed about any changes in their financial status. Sell a range of ...
Director, Social

5 days ago

MKTG Sports + Entertainment New York, United States

**Company Description** · MKTG S+E is a global integrated agency that harnesses the power of sports and entertainment to impact human behavior through meaningful marketing solutions and experiences. Our key differentiator is "knowing people better than anyone else" and using deep ...
Sales Manager, Mid Market Account Manager

1 week ago

monday New York, United States

**About The Role**: · As the Sales Manager, you will be responsible for growing and developing our account management team by providing expert level sales knowledge and coaching while also pushing for process improvement and strategically leading the team to exceed goals. · - · * ...
Kafka Admin

2 days ago

BSL consulting LLC New York, United States

**Job Role: Kafka Admin** · **Location: New York, NY (Onsite)** · **Job Type: Full Time(Permanent)** · **Note**: Visa sponsorship/transfer not available · **Experience level**:8 Years · **Qualifications**: · - Develop Python-based Kafka consumers and producers to enable efficient ...
Aircraft Support Technician

1 week ago

JetBlue Airways Corporation Jamaica, United States

**Position Summary** · The Aircraft Support Technician will be responsible for executing the interiors maintenance program. Duties will include identifying, repairing and replacing components primarily pertaining to the interiors of the aircraft. The position will be covering a 2 ...
Associate, Underwriting

1 week ago

Chubb New York, United States

Chubb Healthcare is an industry leader, offering depth of expertise and a full breadth of products and services to many segments of the Healthcare industry. Our team is designed to cater to the dynamic needs of healthcare customers. Underwriters work together to tailor insurance ...
Property Field Claims Adjuster

1 week ago

American Family Insurance Newark, United States

At American Family Insurance Claims Services (AFICS, Inc.), we're embarking on a transformation of our claims capabilities to put customers at the center of what we do best - protecting and restoring their dreams when they need us most. We're using our expertise, technology and n ...
Global Accounts Receivable Manager

1 week ago

monday New York, United States

**Please note that this is a hybrid position of 3 days/week in our NYC office** · **About The Role**: · - Lead and develop a global AR collection team, including team building, mentoring, training and assignment prioritization · - Provide the team with vision, clear expectations ...
Training Specialist

1 week ago

Rose Associates Inc. New York, United States

**Overview** · **Key Responsibilities** · - Design and deliver engaging training sessions, workshops, and seminars using a variety of instructional techniques and formats. · - Assist in creating and distributing training materials and resources to support learning initiatives. · ...
Procurement Analyst

1 week ago

Division of Information Technology - NYC Department of Health and Mental Hygiene Long Island City, United States

The New York City Department of Health and Mental Hygiene (DOHMH) is the nation's leading public health agency protecting and promoting health of all New Yorkers. Our 7,000-plus team members bring an extraordinary array of languages, cultures, and experiences to bear on the work ...
Assistant Property Manager

1 week ago

Rose Associates Inc. Stamford, United States

**Overview** · Rose Associates is your gateway to innovative real estate solutions. With nearly a century of expertise since 1925, we're a leading force in New York City's dynamic market. Join us as an Assistant Community Manager, supporting our vibrant residential communities. E ...