Jobs in the United States

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Added 6 mins ago
G
Truss Designer
GPAC
Grand Junction, CO
- $65,000 to $77,000 USD / year
Review other designers work as part of a double check system to reduce design errors prior to putting paperwork into manufacturing.
Added 30 mins ago
Data Engineer/Architect
Leidos
Remote, United States
Leidos has an exciting opportunity for an experienced Data Engineer/Architect to support the design of a new data foundation. This foundation will support generative AI applications,…
Added 30 mins ago
Electrical Commissioning Engineer II
Bureau Vertias North America
VA
…This position is also responsible for participating in the MEP design process, witnessing and/or performing the static and dynamic testing of mechanical, electrical, and controls systems,…
Added 30 mins ago
Electrical Commissioning Engineer 1.5
Bureau Vertias North America
VA
…This position is also responsible for participating in the MEP design process, witnessing and/or performing the static and dynamic testing of mechanical, electrical, and controls systems,…
Added 30 mins ago
Mechanical Commissioning Engineer I
Bureau Vertias North America
VA
…This position is also responsible for participating in the MEP design process, witnessing and/or performing the static and dynamic testing of mechanical, electrical, and controls systems,…
Added 30 mins ago
Network Engineering/Operations Site Lead
Leidos
Fort Belvoir, VA
…the technical expertise of the engineering team for detailed design and…
Added 30 mins ago
Expert Level Systems Engineer
SHINE Systems & Technologies
Fort Belvoir, VA
…evaluation, maintainability and analysis across the National System of Geospatial-intelligence (NSG), Allied System of Geospatial-intelligence (ASG) and Federal Agencies to ensure timely…
Added 30 mins ago
Cyber Hardware Reverse Engineer
CACI International
Sterling, VA
…analyzing embedded binaries, and investigating RF data to identify system behavior. An ideal candidate can balance multiple projects in a fast-paced, interdisciplinary, R&D environment and…
Added 30 mins ago
Senior Data Engineer (AWS & Databricks)
General Dynamics Information Technology
Fairfax, VA
The Senior Data Engineer will be responsible for designing, building, testing, and maintaining scalable data engineering components and platform services that power the CMM Program . This…
Added 31 mins ago
ENGINEER SOFTWARE 1
Huntington Ingalls Industries
Newport News, VA
…equipment designers and/or hardware engineers in the planning, design, development, and utilization of electronic data processing systems for product and commercial software. Determines…
Added 31 mins ago
SETA Systems Engineer (Mid)
Trinzic
Chantilly, VA
KBR is seeking a Systems Engineer (SETA) to support our customer. The Technical Professional (SETA) provides systems engineering and analytical support to help inform national security…
Added 31 mins ago
Software Development Engineer, Leo Space Security
Amazon
Arlington, VA · Herndon, VA
We are looking for a software development engineer to join the founding cohort of the Engineering and R&D team within Leo Space Security. The team defends the manufacturing lines, launch…
Added 31 mins ago
Information Systems Security Engineer (ISSE)
Amazon
Arlington, VA
We are seeking a Senior Information Systems Security Engineer (ISSE) to raise the security bar for a portfolio of classified national security systems. You will work backward from mission…
Added 31 mins ago
Pulsed Power Engineer, Senior
BOOZ, ALLEN & HAMILTON, INC.
King George, VA
…weapon s and combat systems. That's why we need an electrical engineer like you who spe cia lizes in high-power RF or pulsed power to help us design and develop systems that can operate…
Added 31 mins ago
Electrical Engineer, Mid
BOOZ, ALLEN & HAMILTON, INC.
Dahlgren, VA
…use in complex environments. That's why we need an electrical engineer like you who spe cia lizes in hardware to help us research, design, procure, and develop targets and target sets for…
Added 31 mins ago
ENGINEER ELECTRICAL 1
HII
Newport News, VA
…solution architects, technical subject matter experts, and system users. We collaborate together at the forefront of technology, manufacturing, and integration of the most powerful and…
Added 31 mins ago
ENGINEER ELECTRICAL 5
HII
Newport News, VA
We are seeking an Electrical Engineer 5 to serve as the technical project lead for the next-generation attack submarine electric plant. Reporting to the E11 Manager of the Future Propulsion…
Added 31 mins ago
OPIR Systems Engineer
BOOZ, ALLEN & HAMILTON, INC.
Chantilly, VA
At a certain point, experience-based system design can start to look like clairvoyance. When you've developed so many systems that you can not only orchestrate the best solution for any…
Added 31 mins ago
Zero Trust Engineer, Lead
BOOZ, ALLEN & HAMILTON, INC.
McLean, VA
You will oversee the full lifecycle of secure network architecture-from conceptual design through implementation, sustainment, and continuous improvement-ensuring solutions are scalable,…
Added 31 mins ago
Multi-Physics Systems Engineer, Mid
BOOZ, ALLEN & HAMILTON, INC.
Arlington, VA
As a systems engineer on our team, you'll have the chance to design the newest and best systems in support of our growing client and customer base. Your technical expertise will be vital as…
Added 1 hour ago
Senior Software Engineer (Data Engineering)
Workday, Inc.
CA · GA
You are a highly motivated and skilled Software engineer with a passion for data engineering and machine learning. You strive to apply technology to drive real impact on Workday's business…
Added 1 hour ago
SS
Senior Substation Structures & Equipment Engineer
Strategic Staffing Solutions
Tampa, FL
- $130,000 to $150,000 USD / year
We are seeking a Senior Electrical Engineer specializing in substation structures and equipment to support major capital projects and electric delivery infrastructure. This role provides…
Added 2 hours ago
Software Engineer 2
Dell
Austin, TX
As a Software Engineer, you will implement features, fix defects, and contribute unit/integration tests under guidance. You will learn best practices and participate in design discussions.
Added 2 hours ago
UO
Guidance, Navigation, & Control Systems Test Engineer
University of Colorado Denver
Boulder, CO
- $34,986 USD / year
LASP is looking for a Guidance, Navigation, & Control (GNC) Systems Test Engineer to join the spacecraft team for a deep space mission that will tour the inner solar system and explore the…
Added 2 hours ago
BA
Modeling and Simulation Engineer
Booz Allen Hamilton
Colorado Springs, CO
- $86,800 to $198,000 USD / year
Design and tailor software solutions using high-level programming language such as Java, C++, and Python to inform modeling, wargaming, operational concepts and force design…

Nextern

Sr. Quality Assurance Engineer

Maple Grove, MN, United States

Salary range: $100,000 to $135,000 depending on skills and experience

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Job details

Pay: Salary range: $100,000 to $135,000 depending on skills and experience
Experience: 5+ years of experience in Quality Assurance role in a medical device development environment
Posting language: English
Posted: Nov 5, 2026

Original job description

Please note - No sponsorship or transfer of sponsorship is available for this role, including but not limited to OPT and H-1B

At Nextern, we inspire with passion, impact with significance, and act with integrity. Nextern partners with OEMs, clinicians, and innovators to design, develop, and manufacture world-class medical devices across the full product lifecycle. From single-use disposables to fully integrated systems to precision components, our teams work as an extension of yours to solve patient needs and improve lives worldwide. This role is responsible for operational quality input and deliverables for manufacturing programs throughout the product lifecycle. Quality Assurance Engineers will also support development activities as they prepare to launch into commercial manufacturing, such as manufacturing readiness, audits, and clinical builds to ensure a smooth transition and continuously accurate and compliant Design History File. All engineering functions are responsible for compliance with the Quality System and relevant regulations and standards, continuous improvement, and as needed, professional interaction with Nextern Customers.

RESPONSIBILITIES

Author and approve SOPs, work instructions, and forms. Support internal audits and maintain inspection readiness across the quality system.
Compile and trend quality metrics to identify systemic issues. Present actionable insights to leadership and drive implementation of corrective and preventive actions.
Oversee incoming inspection per approved sampling plans. Disposition nonconforming materials and coordinate supplier corrective actions to address recurring quality issues.
Provide quality oversight for IQ/OQ/PQ qualification activities. Review and approve protocols, reports, and change orders. Evaluate regulatory impact of equipment changes prior to implementation.
Manage nonconformances and CAPAs from initiation through effectiveness verification. Lead root cause analysis using structured methods (5-Why, fishbone). Trend data and report findings at management review.
Act as the quality point of contact for production.
Review batch records and travelers for GMP compliance.
Support line clearances, first-article inspections, and process change reviews.
Draft, collaborate, and approve product and engineering work orders.
Create and maintain up-to-date product Design History Files (DHF).
Advise project teams and lead by example in best-practices for Quality and Regulatory Compliance.
Own, review, and approve changes ensuring impacts and resulting action/implementation (or lack thereof) are properly documented and executed.
Receive, investigate, and document product complaints, interacting with customers as applicable.
Support audits as Subject Matter Expert (SME) for QMS processes and product DHFs.
Drive Product Lifecycle Management (PLM) architecture and changes, as needed.

Requirements

QUALIFICATIONS

Required:

Bachelor's Degree (BS) in life science discipline or equivalent combination of education and experience.
5+ years of experience in Quality Assurance role in a medical device development environment
Experience working in quality systems as defined in 21 CFR 820 and ISO 13485.
Development project team member on complex medical device development programs, including systems
Understanding of ISO 14971 and application of risk management to product development and processes.
Demonstrated technical expertise and leadership in quality.
High attention to detail, organization, and accuracy.
Instinctual capability for creative thinking and proposing novel solutions
Strong ability to communicate (written and verbally) within and across disciplines and organization structures.
Demonstrated use of quality tools and methodologies (e.g. nonconformance, CAPAs, root cause analysis, etc..).
Experience with Product Lifecycle Management (PLM) software (e.g Windchill, Agile, Propel)
Intermediate to advanced proficiency with MS Office Suit (Word, Excel, PowerPoint, Project, Outlook).

Preferred:

Familiarity with statistical software, such as Minitab, preferred.

Salary range: $100,000 to $135,000 depending on skills and experience

Benefits

Health Care Plan (Medical, Dental & Vision)
Retirement Plan with Company Match
Paid Time Off, Personal Days, AND Birthday Holiday!
Lifetime Membership Subsidy and Wellness Resources
Life Insurance (Basic, Voluntary & AD&D)
Family Leave (Maternity, Paternity)
Short-Term & Long-Term Disability
Taco Thursdays!!!

Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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More about this job

Skills

Quality assurance
Regulatory compliance
Process improvement
Internal auditing
Inspection
Root cause analysis
Good manufacturing practices
PLM
Quality control systems
Risk management
Leadership
Attention to detail
Think creatively
PTC Windchill
Agile
Microsoft Office
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Microsoft Outlook
Minitab

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