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Added 10 mins ago
Specialist, Software Engineer (Cloud Developer)
L3Harris
Patrick Air Force Base, FL
We are seeking a highly skilled and motivated Specialist, Software Engineer/Cloud Developer to join our team. The ideal candidate will hold an active TS/SCI clearance and work onsite at…
Added 18 mins ago
Sr Forward Deployed Engineer (FDE), AWS Forward Deployed Engineering, US Government
Amazon Web Services, Inc.
Jessup, MD · Arlington, VA · Seattle, WA · New York, NY · Denver, CO · Herndon, VA
A Forward Deployed Engineer (FDE) embeds directly inside a strategic enterprise customer to design, build, deploy, and run AI-powered production systems alongside the customer's engineering…
Added 18 mins ago
Software Development Engineer II, DC Bridge
Amazon Data Services, Inc.
Denver, CO
Help us push the availability and reliability of cloud infrastructure to new heights! The AWS Data Center Systems team builds services to monitor and data center infrastructure controls…
Added 18 mins ago
Forward Deployed Engineer (FDE), AWS Forward Deployed Engineering, US Government
Amazon Web Services, Inc.
Jessup, MD · Arlington, VA · Seattle, WA · New York, NY · Denver, CO · Herndon, VA
A Forward Deployed Engineer II (FDE II) embeds directly inside a strategic enterprise customer to independently design, build, deploy, and run AI-powered production systems alongside the…
Added 20 mins ago
Systems Engineer SME
Govcio LLC
Tampa, FL
GovCIO is currently seeking a Systems Engineer SME to provide expert-level systems architecture, engineering integration, and technical assurance for complex, multi-vendor infrastructure…
Added 23 mins ago
Product Development Engr. II
Technibilt Ltd dba Wanzl NA
Denver, NC
The Design and Development Engineer II role is a high-energy, hands-on position within the New Product Development (NPD) team, dedicated to driving the creation, refinement, and scaling of…
Added 39 mins ago
Network Engineer
MANTECH
Norfolk, VA
MANTECH seeks a motivated, career and customer-oriented Network Engineer to join our team in Norfolk, VA. This role is 100% on-site.
Added 56 mins ago
IAM Engineer I, II, III, or Senior
Tri-State Generation and Transmission Association, Inc.
Westminster, CO
The IAM Engineer is responsible for engineering, operating, and continuously improving Tri-State’s identity and access management (IAM) capabilities so that the right people and systems…
Added 1 hour ago
Site Reliability Engineer
SpaceX
Bastrop, TX
The ideal candidate has strong software engineering fundamentals and a passion for infrastructure: reliability, stability, proactive maintenance, and scalability. You understand the system…
Added 1 hour ago
Valves Components Engineer II
Relativity Space
Long Beach, CA
…creatively improving existing designs to enhance performance, reliability, and…
Added 1 hour ago
MSAT Engineer II
HUMACYTE GLOBAL INC
Durham, NC
The MSAT Engineer II is responsible for providing engineering expertise and technical support for Humacyte’s commercial and clinical manufacturing processes. This role serves as a general…
Added 1 hour ago
Engineer I- Sr. (Utility)
Entergy
Little Rock, AR
This position will be filled as Engineer I, II, III or Sr. depending on experience level.
Added 1 hour ago
Electrical Engineer III
Nomad GCS
Columbia Falls, MT
Nomad GCS is currently seeking a Level III Electrical Engineer. Please note the Level III Expectation in red below.
Added 1 hour ago
Manufacturing Engineer II
FEI Company
Hillsboro, OR
…ion beam (FIB) columns, and their sources. The Manufacturing Engineer II role is responsible for providing design and process solutions to both legacy and new products. This role requires…
Added 1 hour ago
Site Reliability Engineer II
Navan
CA or San Francisco, CA · Palo Alto, CA
…exciting challenges ahead and we’re looking for a passionate Site Reliability Engineer to join our team remotely in Dallas, TX or Austin, TX. As an SRE you will design and develop tooling,…
Added 1 hour ago
Site Reliability Engineer II
Axon
Seattle, WA
As a Site Reliability Engineer on the Kubernetes team in Axon's Compute Platform Engineering (CPE) organization, you'll help run and evolve the platform that Axon's products run on: a…
Added 1 hour ago
Site Reliability Engineer II
Axon
Boston, MA · Seattle, WA
As a Site Reliability Engineer on the Kubernetes team in Axon's Compute Platform Engineering (CPE) organization, you'll help run and evolve the platform that Axon's products run on: a…
Added 1 hour ago
Senior Avionics Test Engineer
Muon Space
San Jose, CA
Muon Space is seeking an experienced and hands-on Senior Avionics Test Engineer to join our team in San Jose, CA. In this role, you will own the architecture, development, and scaling of…
Added 1 hour ago
Engineer I - Structures
American Bureau of Shipping
Harahan, LA · New Orleans, LA
The Engineer I performs engineering design review and analysis assignments normally involving a major project or several smaller, less complex projects. These projects, by nature of their…
Added 1 hour ago
Lead Supplier Development, Industrialization & Quality Engineer - Battery Cell
Rivian
Irvine, CA
Added 1 hour ago
Automation Engineer II (AUTOM006871)
RBC
Tucson, AZ
Sargent Aerospace & Defense is seeking a hands-on Automation Engineer II to design, integrate, troubleshoot, and sustain industrial control and automated test systems. This role will place…
Added 1 hour ago
B
Engineer
Bowhead
Crane, IN
- $73,000 to $75,000 USD / year
Bowhead seeks a Engineer to join our team at the Naval Surface Warfare Center in Crane, IN. The Engineer will provide technical and engineering support services to the Strategic Systems…
Added 2 hours ago
Senior Network Engineer
LEIDOS, INC.
Camp Springs, MD
Leidos Digital sector is seeking an experienced Senior Network Engineer to support mission-critical, enterprise-scale network infrastructure on the AFNCR ITS program at Joint Base Andrews…
Added 2 hours ago
Senior Network Engineer Deputy Team Lead
LEIDOS, INC.
Washington, DC
Leidos Digital sector is seeking an experienced Senior Network Engineer Deputy Team Lead to support mission-critical, enterprise-scale network infrastructure on the AFNCR ITS program at…
Added 2 hours ago
Senior DevOps Engineer
LEIDOS, INC.
Bethesda, MD
Leidos is looking for our next TS/SCI cleared Senior DevOps Software Engineer to join a high energy team building and deploying a cutting edge technology stack in support of the DIA NDOC…

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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