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Quality Engineer - 2nd Shift
GTI Fabrication
Goodyear, AZ
- $85,000 to $110,000 USD / year
GTI is seeking a detail-oriented and driven Quality Engineer to support and enhance our ISO 9001 Quality Management System (QMS) while ensuring product quality, operational excellence, and…
Added just now
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Quality Engineer - 1st Shift
GTI Fabrication
Goodyear, AZ
- $85,000 to $110,000 USD / year
GTI is seeking a detail-oriented and driven Quality Engineer to support and enhance our ISO 9001 Quality Management System (QMS) while ensuring product quality, operational excellence, and…
Added just now
Engineer- Controls II USA (Crew C)
First Solar (US)
New Iberia, LA
…PLC/HMI programing, perform vendor equipment check-out, equipment/system start-ups, data collection and optimization of control…
Added just now
Quality Engineer
Performance Seats
Spartanburg, SC
…composites manufacturing will be taught on the job, but the Quality Engineer will be leading work to define and establish quality processes in pursuit of an ISO 9001…
Added 1 min ago
Quality Assurance Engineer
Tosoh Bioscience, Inc.
Grove City, OH
Under the direction of the Quality Assurance Manager, the Quality Assurance Engineer performs critical Tosoh Bioscience Inc. (TBI) functions in support of TBI’s Quality System in compliance…
Added 1 min ago
Electrical Engineer
QPS Employment Group
Davenport, IA
Added 1 min ago
Senior Software Engineer Seeker Market Expansion
BAE Systems
Cedar Rapids, IA
You will contribute to the development of complex embedded systems utilizing Xilinx System-on-Chip (SoC) FPGAs and System-on-a-Module (SOM) architectures leveraging ARM processors.
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Data Scientist 1
Baylor Scott & White Health
Des Moines, IA
…Baylor Scott and White is the largest not-for-profit healthcare system in Texas that empowers you to live…
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Maintenance Engineer
Trinity Health
DES MOINES, IA
Clears and resents the Pneumatic tube system as requested while maintaining the plant in a clean and orderly condition
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Core Senior .NET Software Engineer
Evolent
Des Moines, IA
…care, we seek to connect the pieces of fragmented health care system and ensure people get the same level of care and compassion we would want for our loved…
Added 2 mins ago
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Regional Maintenance Manager
CBRE
Des Moines, IA
- $200,000 to $210,000 USD / year
…maintaining continuity throughout to provide overall quality control for all…
Added 2 mins ago
Tech Lead
LEIDOS, INC.
Chantilly, VA
…Service (SaaS) offerings. In the role, you will be the lead engineer of a team taking requirements through design and technical implementation to delivery, participate in…
Added 2 mins ago
System Safety Engineer
Dynetics, Inc
Huntsville, AL
Leidos Defense is seeking a System Safety Engineer to join a matrixed organization of systems engineers, model-based systems engineers, and specialty systems engineers. This System Safety…
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Senior DevSecOps Engineer
LEIDOS, INC.
Gaithersburg, MD
Leidos is seeking an innovative, mission-driven Senior DevSecOps Engineer to support the Chinook Program serving our Intelligence Community (IC) customer. In this role, you'll help ensure…
Added 2 mins ago
Sr Electrical Engineer
Dynetics, Inc
Albuquerque, NM · Huntsville, AL
Act as a certified test conductor or lead verification engineer to establish comprehensive system-level test plans, environmental stress screening, HWIL integration, and launch-readiness…
Added 2 mins ago
Sr Surety Engineer
Dynetics, Inc
Albuquerque, NM · Huntsville, AL
Leidos Defense Systems is seeking a highly motivated Sr Surety Engineer who loves collaboration and being a part of something big, to join our team. This role drives the implementation of…
Added 2 mins ago
Sr Mechanical Engineer
Dynetics, Inc
Albuquerque, NM · Huntsville, AL
Leidos Defense Systems is seeking a highly motivated Sr Mechanical Engineer who loves collaboration and being a part of something big, to join our team. This role drives the implementation…
Added 2 mins ago
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Jr. Software Engineer
NBCUniversal
Universal City, CA
- $62,000 to $80,000 USD / year
The IPAOT team at NBCUniversal is looking for a passionate and curious Jr. Software Engineer to help design, build, and maintain applications supporting content protection, investigations,…
Added 3 mins ago
Painter
Southernmost Beach Resort
Key West, FL
The Maintenance Engineer Painter is responsible for ensuring that the property is maintained in the best possible condition at all times with a focus on painting throughout the property.
Added 4 mins ago
Software Engineer (Python, APIs, OCP/Kubernetes, Nvidia GPUs)
PNC Bank NA
PA · Strongsville, OH
…opportunity to contribute to the company’s success. As a Software Engineer (Python, APIs, OCP/Kubernetes, Nvidia GPUs) within PNC''s DNA ML Ops Tech organization, you will be based in…
Added 4 mins ago
Senior Instrument & Controls Engineer
Tetra Tech, Inc
San Diego, CA
Glumac, a Tetra Tech Company, is seeking an experienced Senior Instrumentation & Controls (I&C) Engineer to join our engineering team at our San Diego, CA office. This opportunity is ideal…
Added 4 mins ago
Senior Instrument & Controls Engineer
Tetra Tech, Inc
San Francisco, CA
Glumac, a Tetra Tech Company, is seeking an experienced Senior Instrumentation & Controls (I&C) Engineer to join our engineering team at our San Francisco, CA office. This opportunity is…
Added 5 mins ago
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Controls Engineer - Maintenance
Jobot
Sidell, FL
- $72,500 to $85,000 USD / year
We are seeking a passionate, experienced, and innovative Permanent Controls Engineer to join our team in the Manufacturing industry. The ideal candidate will have a solid background in…
Added 5 mins ago
Software Engineer – Emulation and Automated Test
Intuitive
Sunnyvale, CA
The Multiport Software Group within Intuitive has an immediate opening for a Software Engineer to support automated test and the internal da Vinci emulator. You will be on the team…
Added 6 mins ago
Advanced Systems Engineer
Aerospace
Phoenix, AZ
As an Advanced Systems Engineer within Honeywell Aerospace, you will play a vital role in the design, development and implementation of cutting-edge Flight Display Systems and Avionics…

Actalent

Quality Engineer

Edison, NJ, United States

$100,000 to $120,000 USD / year

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Job details

Pay: $100,000 to $120,000 USD / year
Experience: 5+ years of quality engineering experience in the medical device industry.
Posting language: English
Posted: Nov 4, 2026

Original job description

Job Title: Quality EngineerJob DescriptionThe Quality Engineer leads the implementation, maintenance, and continuous improvement of a comprehensive Quality Management System for Class II medical devices. This role provides strategic direction for product quality and reliability, ensures compliance with ISO 9001:2015 and FDA requirements, and drives a culture of continuous improvement across the organization. The Quality Engineer collaborates closely with cross-functional teams to support new product development, supplier quality, and operational excellence.Responsibilities

Implement and maintain a robust quality program aligned with ISO 13485 and FDA requirements for medical devices.
Maintain, review, and continuously improve the Quality Management System based on ISO/IEC 9001:2015 and upcoming standards.
Develop, review, and maintain the quality manual, policies, objectives, procedures, work instructions, and forms required to comply with ISO 9001:2015 and FDA requirements for Class II medical devices.
Prepare for external audits and manage all communication with third-party certifying agencies and the FDA during audits, inspections, and investigations.
Maintain complete and accurate Quality Management System records to ensure readiness for external audits.
Develop and maintain internal audit programs to proactively identify compliance issues and drive relevant changes to the Quality Management System.
Review internal quality control processes and coordinate with internal departments to ensure adherence to ISO and FDA requirements.
Interface with Product Development, Engineering, Purchasing, and Logistics teams to provide expert quality guidance throughout the product lifecycle.
Collaborate with the sourcing team to drive supplier quality performance and ensure suppliers meet established quality standards.
Support operations facilities during customer and third-party audits, including developing and implementing effective corrective actions as needed.
Provide strategic direction for product quality and reliability objectives and oversee the implementation and management of the Quality System.
Implement and promote a culture of continuous improvement to support the achievement of product quality and reliability goals.
Coordinate and lead cross-functional projects and special initiatives related to quality, compliance, and process improvement.
Support cross-functional teams in the implementation of new product development projects, ensuring quality and regulatory requirements are met.
Create and foster a positive working environment that encourages creative thinking, collaboration, and engagement across teams.

Essential Skills

Bachelors degree in engineering.
5+ years of quality engineering experience in the medical device industry.
Proven experience with ISO-based Quality Management Systems, including ISO 9001:2015.
Hands-on experience implementing and maintaining quality programs for medical devices.
Demonstrated experience working with FDA requirements for Class II medical devices.
Strong knowledge of FDA regulations and audit expectations for medical device manufacturers.
Experience preparing for and supporting external audits, including third-party and regulatory audits.
Ability to develop, maintain, and improve quality manuals, policies, procedures, work instructions, and forms.
Experience developing and executing internal audit programs for Quality Management Systems.
Strong collaboration skills with Product Development, Engineering, Purchasing, Logistics, and Operations teams.
Proven ability to drive supplier quality performance in partnership with sourcing or supply chain teams.
Experience supporting operations during customer and third-party audits and developing corrective actions.
Demonstrated ability to lead quality initiatives that support product reliability and continuous improvement.

Additional Skills & Qualifications

Experience with ISO 13485 or similar medical device quality standards.
Familiarity with ISO/IEC 9001:2015 and upcoming revisions or related standards.
Background in implementing and sustaining a culture of continuous improvement.
Experience coordinating cross-functional teams and managing special projects related to quality or new product development.
Strong communication skills for interacting with internal teams, external auditors, and regulatory bodies.
Ability to influence and guide teams in adopting quality best practices and process improvements.
Experience in a strategic quality role with responsibility for product quality and reliability objectives.

Work EnvironmentThe role is based at a fast-paced operations site in Edison, NJ. The Quality Engineer works closely with on-site operations, engineering, and cross-functional teams in a dynamic environment focused on medical device production and compliance. The position involves regular interaction with internal departments, suppliers, and external auditors, as well as active participation in audits, investigations, and project meetings. Job Type & LocationThis is a Permanent position based out of Edison, NJ. Pay and BenefitsThe pay range for this position is $100000.00 - $120000.00/yr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Medical/Dental insurance (some employee contribution is required) Company paid vision and life insurance. Transit check and 125 medical plans. 401k with a company match. Paid vacation and sick time. Discretionary bonuses and profit sharing. Job Type & LocationThis is a Permanent position based out of Edison, NJ. Application DeadlineThis position is anticipated to close on Nov 18, 2026. Workplace TypeThis is a fully onsite position in Edison,NJ.About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

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More about this job

Skills

ISO 9001
Medical devices
Quality assurance procedures
Communication skills
Inspection
Auditing
Regulatory compliance
Quality control
Procurement
Logistics
Process improvement
Think creatively
Collaboration
Supply chain management

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