Jobs in the United States

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Tech Professional, Quality Systems, AI
Johnson & Johnson Services Inc. Legal Entity
Raynham, MA
Analyzes quality system data to identify trends, recurring issues, and process bottlenecks, and translates findings into system and process improvement recommendations.
Added 1 min ago
Software Development Test Engineer
Cisco Systems, Inc.
Richardson, TX
As a Wi-Fi QA Engineer, you will own assigned test areas from requirements review through release. You will design and implement integration plans covering functionality, interoperability,…
Added 14 mins ago
J
Telecom Engineer
Jobgether
Remote, United States
- $73,000 to $95,000 USD / year
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Telecom Engineer based in the United States.
Added 14 mins ago
Senior Principal Engineer – Instrument & Controls
Jobgether
Remote, United States
…and next steps. Our partner is looking for a Senior Principal Engineer – Instrument & Controls based in Houston, Texas, United…
Added 14 mins ago
Director, Compliance & Quality Systems
Jobgether
Remote, United States
We are seeking an experienced quality and compliance leader to own and advance a comprehensive Quality Management System (QMS) within a regulated laboratory environment. You will lead the…
Added 14 mins ago
Cloud Security Architect (Sr)
Jobgether
Remote, United States
…DevSecOps environment. Your contributions will directly strengthen system resilience, security, and operational efficiency across critical defense…
Added 14 mins ago
Project Engineer
OHM Advisors
Cleveland, OH
Professional Engineer (PE) license required in one or more of the following states: Michigan, Florida, Indiana, Illinois, Tennessee, or Ohio
Added 15 mins ago
Mechanical Engineer
OHM Advisors
St. Petersburg, FL
As a Mechanical Engineer, you will collaborate with internal and external project team members, clients, contractors, and other technical experts to deliver effective HVAC, plumbing and…
Added 15 mins ago
Substation Construction and Apparatus Manager
Snohomish County PUD
Everett, WA
…and drives continuous improvement initiatives that support system reliability and the District's long-term strategic goals. Safety is the highest priority and is embedded in all activities,…
Added 15 mins ago
Senior .NET Software Engineer
OkWhen
Remote, United States
This is not a ticket-taking role. We need an engineer who can understand the existing system, make sound technical decisions, and follow work through from discovery to production.
Added 17 mins ago
USCG Licensed Assistant Engineer 2026
O'Hara Corporation
Seattle, WA
Assistant engineers work at least 13 hours per day, 7 days per week · Work at least 16 ½ hours per day, 7 days per week for the duration of the contract
Added 22 mins ago
Product Development Engineer
Altera Corporation
San Jose, CA
Altera is looking for a Product Development Engineer to support engineering development, validation, and debug activities in a hands-on lab environment. You will help qualify and improve…
Added 26 mins ago
Technical Specialist - Propulsion Hydraulics - Warren MI
Military Spouse Jobs & VetJobs
United States
We are looking for an experienced engineer to lead the virtual development of propulsion hydraulic systems. This person will help hardware teams make better design decisions for engine…
Added 28 mins ago
Embedded Software Engineer VI
Voyager Technologies, Inc.
Folsom, CA
The Level VI Embedded Software Engineer serves as a senior technical leader responsible for the architecture, design, development, integration, and verification of safety-critical embedded…
Added 30 mins ago
Software Development Test Engineer
Cisco
Richardson, TX
As a Wi-Fi QA Engineer, you will own assigned test areas from requirements review through release. You will design and implement integration plans covering functionality, interoperability,…
Added 30 mins ago
EG
Senior Systems Administrator / Infrastructure Engineer
Eliassen Group
Jefferson City, MO
- $65 to $75 USD / hour
Our client seeks a senior-level Systems Administrator or Infrastructure Engineer to administer Linux and Windows Server environments, manage AWS services, and drive automation and…
Added 34 mins ago
Facility Engineer II - Omak
Confluence Health
Omak, WA
Must possess basic computer skills related to Windows navigation, mouse usage, keyboarding, email communication and password management
Added 37 mins ago
E&A Engineer
Nestle Operational Services Worldwide SA
Ponda, IN
…engineering with the required competence on Factory Automation System (FAS), Process Control System and Manufacturing Execution System (MES) to effectively support manufacturing operational…
Added 37 mins ago
Senior PCB Design Engineer
Arista Networks
Santa Clara, CA
…Thermal Engineering, and Manufacturing, our engineers innovate on system architectures and ultra-high-speed PCB designs to deliver state-of- the-art networking…
Added 37 mins ago
Production Master Data Engineer
Anduril Industries
Costa Mesa, CA
…of systems is powered by Lattice OS, an AI-powered operating system that turns thousands of data streams into a realtime, 3D command and control center. As the world enters an era of…
Added 38 mins ago
Tech Professional, Quality Systems, AI
Johnson & Johnson Services Inc. Legal Entity
Raynham, MA
Analyzes quality system data to identify trends, recurring issues, and process bottlenecks, and translates findings into system and process improvement recommendations.
Added 46 mins ago
J
Senior Systems Engineer
Jobgether
Remote, United States
- $65 to $75 USD / hour
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Systems Engineer based in the United States.
Added 55 mins ago
B
Machine Learning Engineer, AI
Biohub
Redwood City, CA
- $241,000 to $301,000 USD / year
…capabilities under one roof. We're building a general-purpose system to accelerate scientific discovery, integrating frontier AI models, biological foundation models, and lab capabilities,…
Added 55 mins ago
B
Machine Learning Engineer, AI
Biohub
NY
- $241,000 to $301,000 USD / year
…capabilities under one roof. We're building a general-purpose system to accelerate scientific discovery, integrating frontier AI models, biological foundation models, and lab capabilities,…
Added 56 mins ago
HVAC / Engineer-2
C&W FACILITY SERVICES INC.
VA
Be proficient ¡n the functionality of the BMS/EMS and understand the sequences required for proper building, equipment and system operations.

Nextern

Principal Quality Assurance Engineer

Maple Grove, MN, United States

Salary range: $130,000 to $170,000 based on skills and experience

Apply on apply.workable.com About employer

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Job details

Pay: Salary range: $130,000 to $170,000 based on skills and experience
Experience: 10+ years of experience in medical device manufacturing
Posting language: English
Posted: Nov 6, 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 manufacturing and device quality for commercial devices and manufacturing transfers. Quality engineers own sustaining activities for investigational and commercial device manufacturing, such as changes, audits, nonconformances, CAPAs, and complaint investigations ensuring timely completion of activities. 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

Primarily supports US manufacturing, but may support global manufacturing sites up to 10%
Phase 4-5 Project core team member accountable for product development deliverables including, but not limited to: Process risk assessment (PFMEA); Master Validation Plan(s) and Report(s); Failure/Scrap code identification and maintenance in alignment with process risks; Manufacturing, process monitoring, and product acceptance plans
Draft, collaborate, and approve project deliverables and engineering work orders
Coordinate and execute, as necessary, process output testing (verification/validation)
Create and maintain up-to-date product Device Master Records (DMR)
Compile, analyze, and present product specific Quality metrics for various review forums
Own manufacturing/DHR review as part of complaint investigations
Lead by example in Good Manufacturing Practices (GMP) and Good Documentation Practices (GMP)
Proactively identify redundancy and opportunities for improvement in Quality System requirements
Own, review, and approve changes ensuring impacts and resulting action/implementation (or lack thereof) are properly documented and executed
Identify, own, and execute nonconformance investigations and implementation of corrective and preventive actions, as necessary
Support audits as Subject Matter Expert (SME) for QMS processes and product line manufacturing
Lead Product Lifecycle Management (PLM) architecture and changes, as needed

Requirements

QUALIFICATIONS

Required:

Bachelor's Degree (BS) in engineering discipline or equivalent combination of education and experience.
10+ years of experience in medical device manufacturing
Success working in quality systems as defined in 21 CFR 820 and ISO 13485.
Expert level knowledge and application of GMP, GDP
Intimate understanding of ISO 14971 and application of risk management principles
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..)
Familiarity with common statistical software, such as Minitab
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:

Secondary certification in Quality (e.g. CQE, CQA) or lean (e.g. six sigma) principles preferred

Salary range: $130,000 to $170,000 based 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.

Apply on apply.workable.com About employer

More about this job

Skills

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

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Jobs in the United States