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Lead Instrumentation & Controls Engineer 1 - Nuclear
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…Instrumentation and Controls Engineering group. You will work on major process controls engineering projects in the following…
Added 2 mins ago
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Assistant Transportation Engineer - Traffic Engineering
Department of Transportation
Augusta, ME
- $56,867.2 to $79,747.2 USD / year
If you are a current State of Maine employee, please submit your application through the internal application process using the Find Jobs report in PRISM. Seasonal employees who do not have…
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Sr. Software Development Engineer
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Product Marketing Director
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Global Treasurer
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Assistant Site Superintendent - Custom Residential Construction
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Working with the Site Superintendent, Project Manager, and Project Engineer, you will help keep work organized, identify field issues, and follow through on daily priorities. While the…
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Turnaround Engineer
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FLEX Senior Software Engineer
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Power Electronics Engineer - High Voltage (Starlink)
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Automation Engineer
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Added 6 mins ago
Staff Quality Systems Engineer
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We are searching for the best talent for a Staff Quality Systems Engineer to lead and optimize CAPA and Nonconformance (NC) processes within a regulated medical device environment. This…
Added 6 mins ago
Tool Integration Electrical Engineer I/II
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The Tool Integration Electrical Engineer I/II will drive the embedded systems design and implementation for battery-powered outdoor equipment, with a focus on power electronics, motor…
Added 7 mins ago
Structural Engineer
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Saint Paul, MN
ERA seeks a motivated Structural Engineer who is interested in growing a rewarding career. As a Structural Engineer, you will be responsible for working with a variety of clients, including…
Added 7 mins ago
Structural Engineer
ERA Structural Engineering Inc.
Eau Claire, WI
ERA seeks a motivated Structural Engineer who is interested in growing a rewarding career. As a Structural Engineer, you will be responsible for working with a variety of clients, including…
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Sr. Structural Engineer
ERA Structural Engineering Inc.
Saint Paul, MN
ERA seeks a motivated Sr. Structural Engineer who is interested in growing a rewarding career. As a Structural Engineer, you will be responsible for working with a variety of clients,…
Added 8 mins ago
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DevOps Engineer
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Chicago, IL · 1 N Dearborn St. Chicago, IL
- Up to $10,000 USD / month
You enjoy working directly with clients to bring a project from inception to completion
Added 8 mins ago
CNC Tooling Sales and Application Engineer
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North West Houston, TX
Proactively managing the complete sales process, including prospecting, qualification, consultative sales meetings, product demos, pricing, terms negotiations, and sourcing.
Added 9 mins ago
Senior Tech Delivery Lead Open Text
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May sometimes provide hands-on assistance with exceptionally complex technical solutions, operating as a senior engineer
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Expert Project Engineer
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- $115,973.1 to $169,261 USD / year
The Expert Project Engineer will manage small, minor and major capital projects from end to end and all key components of major capital projects (concept, scope, cost, resources, funding,…
Added 9 mins ago
Quality Principal Engineer II
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Evaluating process methods and equipment to meet performance and quality requirements.
Added 9 mins ago
2 Construction Project Managers- Positions 01714 and 01775
Department of Motor Vehicles
Richmond, VA
Title: 2 Construction Project Managers- Positions 01714 and 01775
Added 10 mins ago
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Senior Transportation Hydraulics Engineer
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- $135,000 to $165,000 USD / year
AECOM is seeking an experienced Senior Transportation Hydraulics Engineer to join our Transportation team in Raleigh, NC. This position will provide technical leadership and engineering…
Added 10 mins ago
Product Development Engineer
Fenner Precision Polymers
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Communicate effectively across departments and participate in cross-functional project teams
Added 10 mins ago
Power Engineer II
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HPE has an immediate need at its Sunnyvale, CA location for a Power Engineer. This position reports to the Manager of Power Systems Development, a subgroup of HPE’s Engineering Services…
Added 10 mins ago
HPE Labs - Principal Research Engineer - HPE Quantum
Hewlett Packard Enterprise
Milpitas, CA
…with high-performance computing (HPC). As a Principal Software Engineer, you will help advance quantum computing from research toward practical applications. You will apply your software…

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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