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Reliability Test Engineer
Actalent
Mountain View, CA
- $60 to $75 USD / hour
Job Title: Reliability Test EngineerJob DescriptionThe Reliability Test Engineer will join a Verification & Validation team to execute environmental qualification strategies, including…
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Planning Engineer
Actalent
Chattanooga, TN
Job Title: Planning EngineerDescription:The Planning Engineer will be responsible for managing projects in an automotive manufacturing environment. The position is 50% hands on and 50%…
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Controls Engineer
Actalent
Sparta, TN
- $50 to $67 USD / hour
Job Title: Controls / Manufacturing EngineerJob DescriptionThe Controls / Manufacturing Engineer develops, improves, troubleshoots, and maintains manufacturing processes, automated…
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Staff Machine Learning Engineer
Walt Disney Pictures
Burbank, CA
- $158,100 to $211,900 USD / year
The Staff Machine Learning Engineer is part of the Creative Technology Platform organization within Studio Technology. This role leads applied deep learning work in computer vision and…
Added 3 mins ago
CO
Chief of Traffic Engineering
City of Jacksonville
Jacksonville, FL
- $67.31 to $79.59 USD / hour
…traffic engineering services, traffic signals and other traffic-control devices, including railroad crossing signals and for operating the streets and highways of the Consolidated…
Added 4 mins ago
PT
Controls and Automation Engineer
Phoenix Tailings
Rochester, NY
- $80,000 to $150,000 USD / year
Troubleshoot control logic, industrial communications, and instrument problems, comparing system data with field conditions to identify the underlying fault
Added 5 mins ago
Sr. System Development Engineer, Amazon Leo
Amazon Kuiper Manufacturing Enterprises LLC
Bellevue, WA
Export Control: This position requires that the candidate selected be a U.S. Citizen to comply with U.S. government-imposed requirements related to the nature of the work and/or where it…
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Automation Engineer
Amazon.com Services LLC
Richmond, VA
As an Automation Engineer, you will play a crucial role in maximizing equipment reliability and operational performance in our fulfillment centers by providing proactive controls automation…
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Sr Electrical Engineer, ALG, Amazon Leo Government
KGS LLC
Redmond, WA · El Segundo, CA · Northridge, CA
The Sr Electrical Engineer will play a pivotal role in the team delivering innovative and fast-paced analysis and design solutions, focusing on satellite and ground system design and…
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Electrical Engineer, Amazon Leo Government, Amazon Leo Government
KGS LLC
Redmond, WA · Northridge, CA
The Electrical Engineer will focus on satellite and ground system design and analysis of electronic components, circuits, and sub-systems. They will be expected to execute a variety of…
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Lead Principal Application Software Engineer
Oracle
Nashville, TN
- $104,600 to $264,100 USD / year
…organization, is seeking a Lead Principal Application Software Engineer (IC5) to lead engineering practices and architecture. Our team modernizes corporate systems, processes, and data,…
Added 6 mins ago
Plant Utilities Engineer 1
SUNY College of Optometry
NY
…applications for a NYS Department of Civil Service Plant Utilities Engineer…
Added 7 mins ago
IT Security Specialist
Farmers Mutual Hail Insurance Company
West Des Moines, IA
…identities, and privileged access to identify security risks and control deficiencies; coordinates remediation with IT teams and system…
Added 8 mins ago
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Product Engineer
Clera
San Francisco, CA
- $120,000 to $200,000 USD / year
- Use SQL and analytics tools to assess product and system performance.
Added 11 mins ago
AI and DSP Applications Software Engineer
ON, CA
We are searching for a self-motivated AI and DSP Applications Software Engineer to join the AI Processor Solutions team, which is responsible for developing machine learning-based…
Added 12 mins ago
Nobel Biocare Quality Engineer, Manufacturing (On-Site Yorba Linda, CA)
Nobel Biocare USA, LLC
United States of America, CA
The Quality Assurance Engineer is responsible to ensure that production processes remain in a state of control, validation and verification activities are robust, and processes consistently…
Added 12 mins ago
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Zero Trust Implementation Lead
TEKsystems
Greensboro, NC
- $66.67 to $83.33 USD / hour
We are seeking an experienced Security Engineer to accelerate execution of an enterprise Zero Trust program across a global retail, corporate office, distribution center, and data center…
Added 12 mins ago
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Field Application Engineer - Data Center Power Electronics
STMicroelectronics
Santa Clara
- $132,100 to $165,100 USD / year
We are seeking a highly skilled Field Application Engineer (FAE) with 6+ years strong expertise in data center power conversion systems. The successful candidate will provide technical…
Added 13 mins ago
NI
Technical Project Manager
NIRA, Inc.
Washington, DC
- From $120,000 USD / year
6+ years of experience as Technical Project Manager, Technical Program Manager, System Engineer, Software Engineer, or a similar role.
Added 14 mins ago
Digital S/W Eng Intm Analyst - Officer
Citi
IRVING, TX · Irving, TX · Irving
The Digital S/W Engineer Intmd Analyst is a developing professional role. Deals with most problems independently and has some latitude to solve complex problems. Integrates in-depth…
Added 15 mins ago
Senior DevSecOps Engineer (Contingent)
Mile Two, LLC
Dayton, OH
Documenting architectures, deployment procedures, standard operating procedures, troubleshooting guides, and system configurations.
Added 15 mins ago
Product Development Engineer – Wiper/Washer (Subject Matter Expert)
Ford
Dearborn, MI · Dearborn
Lead design of new concepts to improve system performance & provide leadership & support for timely implementation.
Added 16 mins ago
Manager, Engineering
Priority Technology Holdings, LLC
Remote, United States
Craft - Hiring, feedback, and performance management operate as a system, not events: the bar is consistent, the assessments are honest, and underperformance is addressed early and…
Added 18 mins ago
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Engineer 6 Sulphur Construction
State of Louisiana
Sulphur, LA
- $38.61 to $69.5 USD / hour
DOTD is seeking an experienced engineer to serve as the Engineer 6 expert while supervising lower-level Engineers or Engineering Technicians.
Added 18 mins ago
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Security & IT Operations Engineer
Prefect
Remote, United States
- $165,000 to $219,000 USD / year
We think of our culture as the operating system of the company. We’ve carefully created a supportive, high-performance environment that empowers our team to do the best work of their…

Nextern

Pr. Quality Assurance Engineer

Maple Grove, MN, United States

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

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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.

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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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