Jobs in the United States

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Added 2 mins ago
Manufacturing Equipment Engineer – EV Battery
K&K Technical
Liberty, NC
Manufacturing Engineer – EV Battery Manufacturing
Added 3 mins ago
Civil Project Manager (Residential)
Trilon Group
Columbus, OH
…of more than 650+ professionals deliver integrated planning, design, engineering and construction…
Added 10 mins ago
AI & Data Science Engineer III
Deloitte US
Dallas, TX
You will bring strong technical, functional and project management solutions to clients with a focus on achieving a high level of performance and quality through delivery of both agile and…
Added 14 mins ago
V
Senior Land Development Project Manager or Engineer
VHB
Tampa, FL
- $135,000 to $160,000 USD / year
PE license required; Florida licensure preferred or ability to obtain within 6 months
Added 16 mins ago
Suspension Technical Expert – Spring System - Leaf and Coil
Ford Global
Dearborn, MI
On-site support for collaboration required targeting 4 days per week
Added 16 mins ago
Senior Electrical Engineer
WSP
Arlington, VA · New York, NY · Pittsburgh, PA · San Antonio, TX · Decatur, AL · Meridian, ID · Denver, CO · San Diego, CA · Tacoma, WA · NY · Huntsville, AL
Review and advice on third-party design documents, procurement lists, and project plans.
Added 16 mins ago
GW
Technician II
Ground Water Treatment
Wharton, NJ
- $24 to $31 USD / hour
Mechanical and basic electrical assembly of projects under the supervision of Superintendent or Project Engineer
Added 18 mins ago
LI
Data Center Market Leader / Senior Project Manager
LJB Inc.
Miamisburg, OH
- $110,000 to $150,000 USD / year
…Dayton, Ohio office. The Data Center Market Leader and Senior Project Manager develops and executes the firm’s strategy for growing its data center portfolio while leading teams that…
Added 18 mins ago
LI
Data Center Market Leader / Senior Project Manager
LJB Inc.
Charlotte, NC
- $110,000 to $150,000 USD / year
…North Carolina office. The Data Center Market Leader and Senior Project Manager develops and executes the firm’s strategy for growing its data center portfolio while leading teams that…
Added 18 mins ago
LI
Data Center Market Leader / Senior Project Manager
LJB Inc.
Houston, TX
- $110,000 to $150,000 USD / year
…Houston, Texas office. The Data Center Market Leader and Senior Project Manager develops and executes the firm’s strategy for growing its data center portfolio while leading teams that…
Added 19 mins ago
Engineer (Relay Settings and Configurations)
Entergy
New Orleans, LA
Performs a wide variety of planning, maintenance, design engineering, project management and construction, and operations activities related to routine, non-routine, and emergency…
Added 19 mins ago
Project Engineer II- Process Controls
Honeywell Technologies
Baton Rouge, LA
YOU MUST HAVE
Added 19 mins ago
Utility Engineer (Transmission/Lines)
Entergy
Baton Rouge, LA
Performs a wide variety of engineering activities associated with transmission line maintenance, design, project management and construction, and operations activities in the LA…
Added 20 mins ago
A
Systems Engineer
Actalent
Chantilly, VA
- $115,000 to $190,000 USD / year
Job Title: Systems Engineer Advanced Radar and Mission SystemsJob DescriptionThis Systems Engineer role focuses on developing advanced radar and mission systems for Navy applications,…
Added 20 mins ago
A
Transportation Project Manager
AECOM
Raleigh, NC
- $140,000 to $185,000 USD / year
Professional Engineer (PE or P.Eng.) license required
Added 22 mins ago
Technical Architect / Technical Lead – MCP & Governed Model Access
LatentBridge
New York, NY
design, architectural governance, and delivery of the enterprise Model Context
Added 24 mins ago
Transportation CAD Tech
Woolpert
Beavercreek, OH · Cincinnati, OH · Cleveland, OH · Columbus, OH · Fort Worth, TX
Must have an Associates degree or technical certification from a technical school or four (4) years related experience
Added 28 mins ago
Civil Engineer II - Structures Section
State of Vermont
Barre, VT
Added 28 mins ago
Civil Engineer I - Structures Section
State of Vermont
Barre, VT
Added 28 mins ago
Civil Engineer III - Structures Section
State of Vermont
Barre, VT
Added 34 mins ago
AE
Agentic AI Infrastructure Engineer II - Core Platforms
American Express
Phoenix, AZ
- $89,250 to $150,250 USD / year
The AI Infrastructure Engineer is responsible for designing, implementing, and maintaining robust, scalable, and efficient infrastructure solutions that support AI-enabled workloads. This…
Added 35 mins ago
PT
Principal Software Engineer
PDS Tech Commercial
Phoenix, AZ
- $120 USD / hour
Drive Advanced SoC Performance Monitoring and Analysis as a Principal Software Engineer!
Added 35 mins ago
PT
Principal Mechanical Design Engineer
PDS Tech Commercial
Phoenix, AZ
- $85 to $100 USD / hour
Lead Advanced Aerospace Engine Design & Analysis as Principal Mechanical Design Engineer!
Added 35 mins ago
Mechanical Engineer-HVAC & Plumbing
Cummings Properties
Woburn, MA
Cummings Properties is seeking an experienced, licensed Mechanical Engineer with 7?10 years of experience in commercial HVAC and plumbing system design to join our in-house engineering and…
Added 35 mins ago
GD
Mechanical Engineer Entry Level
General Dynamics Mission Systems
Pittsfield, MA
- $77,843 USD / year
Creative thinker supporting a team in the preparation of project design, testing, and prototype fabrication

Nextern

Principal Quality Assurance Engineer

Maple Grove, MN, United States

$130,000 to $170,000 USD / year

Apply on jobs.workable.com About employer

Applications open in a new tab.

Job details

Pay: $130,000 to $170,000 USD / year
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

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

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
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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Work requirements

Jobs in the United States