Quality Engineer - Warren, United States - Immucor

Immucor Warren, United States

3 days ago

Description

Quality Engineer - IVD Software

Job Locations

US-NJ-Warren

Job ID

Category

Quality

Overview

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

The Quality Engineer is the subject matter expert for Software as a medical device (SAMD) and/or software as an accessory/component to a medical device, and ensures the software is compliant with all regulations. This role oversees implementation of the project quality management plan(s) and product plans of the organization. He/She helps to ensure the quality, compliance, and integrity of GXP systems used in the development, manufacturing, and distribution of medical devices / In vitro devices (IVD). The role also manages projects from concept to completion; creates and manages project plan, work cross functionally to ensure completion, and ensure adequate training to impacted areas. He/She works effectively with stakeholders to ensure alignment with business objectives, correct prioritization, and successful project delivery and assists with product and process validations, including protocol and report review. If you have the required skills, don't wait, apply today

(This is NOT AN IT POSITION)

This position is not eligible for sponsorship for work authorization. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time.

Quality Engineer/Medical Device/ IVD Software

Responsibilities

Key Accountabilities:

Ability to lead a cross-functional core team in successfully delivering to system-based projects and process improvements. Collaborate cross-functionally to create and execute project plans (scope, schedule, staffing plans, quality, risk management, budget, and procurement) and revise them appropriately to meet changing needs and requirements.
Ensure that upgrades to medical device reagents and software are made in compliance with all applicable regulations. Support quality and regulatory teams in creating/revising technical documentation related to IVDs (reagents and software) and support deliverables required to meet country registration requirements.
Monitor, analyze, and report on GXP system metrics and identify trends and areas for improvement.
Support risk management practices and concepts and applies knowledge to manufacturing operations and software development. Support risk management program associated with commercial and development medical devices.
Engage in the development and improvement of the internal manufacturing processes for existing and new products. Ability to simultaneously manage commercial and development projects.
Update and maintain Design History Files / Technical documentation as needed. Including editing and review of impact and risk assessments for design, process, and risk control activities.
Ensure integration of product regulatory requirements into product specifications and technical documentation.
Partner with internal functional areas as part of the change control process. Support CAPAs and change control associated with product improvements.
Support QA and RA on projects as needed.

Quality Engineer/Medical Device/ IVD Software

Qualifications

Minimum Knowledge & Experience required for the position:

Bachelor's degree in biomedical engineering, biology, chemistry, or related field.
Five or more years' experience within a pharmaceutical and/or medical device company in a quality assurance role (IVD experience preferred).
Graduate degree may substitute for some of the experience, depending on the coursework and pharmaceutical and/or medical device experience in a quality assurance role
At least 2 years experience with software as a medical device (SAMD) and/or accessory to a medical device, required
Knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
Experience with 21 CFR Part 820, ISO 13485, and/or MDSAP
Experience with 21 CFR Part 210/211 may be accepted depending on other related experience.
Experience with IVDR (EU 2017/746) / MDR (EU 2017/745) regulations preferred.
CQE certification, preferred

Quality Engineer/Medical Device/ IVD Software

Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.

Connect With Us

Not ready to apply? Connect with us for general consideration.

Quality Assurance Automation Engineer

1 day ago

Galactic Minds INC Warren, United States

Strong in Automation Testing + Lead + Guidewire/Duck Creek Experience · Need: 10+ Years · ...
Validation Specialist

1 day ago

Aequor Warren, United States

Position: Validation Qualification Specialist · Location: Warren NJ 07059 · Duration: 12+ months (possibility of extension for the right candidate depending on performance) · Pay rate: $51.86/ hour on W2 · Job Description: Validation Qualification Specialist · This role is 100% ...
Commissioning/Qualification Specialist

1 day ago

Pyramid Consulting, Inc Warren, United States

Immediate need for a talented Commissioning/Qualification Specialist. This is a 12+ Months contract opportunity with long-term potential and is located in Warren, NJ (Onsite). Please review the job description below and contact me ASAP if you are interested. · Job ID: · ...
Underwriting Assistant

1 week ago

MSIG Holdings USA, Inc. Warren, United States

MSIG North America continues to grow · Summary/Job Purpose: · Responsible for supporting the underwriting process for multiple lines of insurance coverage which includes property, casualty, workers compensation, umbrella, excess lines, marine and automobile coverages. · Provid ...
System Engineer

2 days ago

NPAworldwide Warren, United States

Global shipping company in central NJ is seeking a System Engineer - Monitoring Engineer. · You will be involved in maintaining, operating, and innovating the firm's corporate infrastructure, ensuring they remain at the cutting edge of technology and service. · You will need to ...
Senior Structural Engineer

1 week ago

PS&S Warren, United States

Overview: · PS&S is an award winning "one-stop shop of architecture and engineering excellence, which was established in 1962. The depth and breadth of our expertise has helped PS&S grow into a firm offering multi-disciplined, full-service architecture, engineering, design, envi ...
Production Manager

10 hours ago

Mauser Packaging Solutions Warren, United States

Responsibilities: · Actively participates in the site's safety and quality management programs. · Participates and practices Lean Manufacturing practices to include Six Sigma, FMEA, 8D Problem Analysis. · Prepares and reviews any and all production, safety and quality reports. De ...
Sr. Principal Laser Engineer

1 week ago

Coherent Warren, United States

Primary Duties & Responsibilities · Lead Laser Engineer - Provide optical engineering leadership to internally and externally funded R&D efforts, with a primary focus on dual-use platforms and advanced laser technology. Lead the design of complex, innovative, state-of-the-art, f ...
Civil Engineer

1 week ago

gpac Warren, United States

I am partnered with a distinguished Civil Engineering Firm, renowned for its multi-disciplinary expertise and headquartered in the metropolitan area. Currently, they are actively seeking a dynamic Project Engineer driven by a commitment to excellence. This firm places a strong em ...
Sr. Principal Embedded Software Engineer

3 weeks ago

Coherent Warren, United States

Job Description · Primary Duties & Responsibilities · Software Architecture and Design: Works as a member of a cross-disciplinary team of systems engineers, optical engineers, electrical engineers, and FPGA engineers to conceptualize a system solution that meets customer require ...
Project Manager, Supply Chain

2 weeks ago

TechDigital Corporation Stafford Twp, United States

This role is required to work in a cross functional and dynamic setting, and therefore requires an individual who can quickly adapt to the changes and manage communications at different levels in the organization. · Experience Required: · • Minimum 6 years of Supply chain plannin ...
Sr Principal FPGA Engineer

1 week ago

Coherent Warren, United States

Job Description · Primary Duties & Responsibilities · FPGA Architecture and Design: Works as a member of a cross-disciplinary team of systems engineers, optical engineers, electrical engineers, and software engineers to conceptualize a system solution that meets customer require ...
Environmental Permitting Specialist Entry Level

2 weeks ago

PS&S Warren, United States

Overview: · Founded in 1962, PS&S has evolved into a unique best-in-class architecture, engineering, surveying, and environmental consulting firm, providing design and consultation services to a wide range of public, corporate, institutional, and commercial clients. PS&S is rank ...
Validation Qualification Specialist

1 week ago

Sunrise Systems inc Warren, United States

Job Title: Validation Qualification Specialist · Job ID: · Location: Warren, NJ, 07059 · Duration: 12 Months contract on W2 · This role is 100% Onsite · Work Schedule: Mon - Fri, Business Hours · 1. PURPOSE AND SCOPE OF POSITION: · The Validation Engineer supports the ...
Validation Specialist

1 week ago

Joulé Warren, United States

Job Title: Validation Specialist Location: Warren, NJ Hours/Schedule: Mon - Fri, Business Hours Type: Contract Responsibilities Performs validation document generation, program management, and protocol execution activities. Interface with Engineering, and end user groups to suppo ...
System Engineer

1 day ago

MSC Mediterranean Shipping Company SA Warren, United States

We're on the lookout for a System Engineer - Monitoring Engineer to join our MSC Tech Office in Warren NJ. This pivotal role will see you maintaining, operating, and innovating our corporate infrastructure, ensuring MSC remains at the cutting edge of technology and service. · Wh ...
Validation Engineer

1 day ago

On-Board Companies Warren, United States

On-Board Services is hiring a Validation Engineer in Warren, NJ · For immediate consideration please send your resume to · Subject Line: Position Title and State you are Located · About Us: · On-Board Services, Incorporated is an on-site contract service provider for a local ...
System Engineer

1 day ago

MSC Mediterranean Shipping Company SA Warren, United States

We're on the lookout for a System Engineer - Monitoring Engineer to join our MSC Tech Office in Warren NJ. This pivotal role will see you maintaining, operating, and innovating our corporate infrastructure, ensuring MSC remains at the cutting edge of technology and service.What Y ...
Validation Specialist

1 week ago

LanceSoft Warren, United States

Job Description: Validation Specialist · Warren, NJOnsite · Work Schedule: Mon - Fri, Business Hours · The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities ...
Validation - Validation Specialist

1 week ago

HonorVet Technologies Warren, United States

Job Description: Validation Specialist · Warren, NJOnsite · Work Schedule: Mon - Fri, Business Hours · The Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities ...