Jobs in the United States

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Added 8 mins ago
Sr Systems Integration Engineer – Radiation Producing Subsystem
x Varian Medical Systems, Inc.
United States
We seek a versatile Systems Engineer for our Linear Accelerator Systems group, supporting radiation-producing subsystems in oncology machines. Responsibilities include contributing to…
Added 13 mins ago
SF
Assistant Chief Maintenance Officer
San Francisco Bay Area Rapid Transit District (BART)
Oakland, CA
- $94.71 to $143.48 USD / hour
…leadership expansion, developing and executing the maintenance control, regulatory compliance, planning and executing of Capital Maintenance projects, quality assurance and warranty…
Added 28 mins ago
Project Engineer I, Construction
Scout Clean Energy
Boulder, CO
Must have a valid current driver license and be able to travel and perform field work · Working from the Boulder office, when not traveling to a project, is required at least 3 days per week
Added 32 mins ago
Field Engineer
JDS Energy & Mining
Fairbanks, AK
JDS Energy & Mining is seeking a motivated and experienced Field Engineer (Civil) with 4–5 years of relevant experience to support field execution on active mining and construction…
Added 38 mins ago
N
Sr. Quality Assurance Engineer
Nextern
Maple Grove, MN
- $100,000 to $140,000 USD / year
Advise project teams and lead by example in best-practices for Quality and Regulatory Compliance.
Added 38 mins ago
N
Principal Quality Assurance Engineer
Nextern
Maple Grove, MN
- $130,000 to $170,000 USD / year
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);…
Added 56 mins ago
Software Development Engineer II
Blue Origin LLC
Seattle, WA
We are seeking a Software Engineer II to design and build Blue Origin's next-generation procurement platform that will reinvent the entire procure-to-pay lifecycle. This role is on the…
Added 1 hour ago
Principal BMS & PMS Controls Engineer
Jobgether
Remote, United States
…steps. Our partner is looking for a Principal BMS & PMS Controls Engineer based in United…
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Qualifications You Must Have:
Added 1 hour ago
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Software Engineer Skill Level 2
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- $78.99 to $99.84 USD / hour
Software Engineer (SWE) Skill Level 2 – Cloud-Based Analytics Developer
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Design Engineering Manager
The businesses of Merck KGaA, Darmstadt, Germany
Austin, TX
Based in Austin, TX, the manager partners with Product Engineering, Manufacturing Engineering, Applications, Project Management, Supply Chain, Quality, and Operations across global sites.…
Added 1 hour ago
Design Engineering Manager
The businesses of Merck KGaA, Darmstadt, Germany
Chandler, AZ
Based in Chandler, AZ the manager partners with Product Engineering, Manufacturing Engineering, Applications, Project Management, Supply Chain, Quality, and Operations across global sites.…
Added 1 hour ago
Test Engineer II
Sierra Nevada Corporation
Sparks, NV
Qualifications You Must Have:
Added 1 hour ago
VE
Project Engineer, Mechanical
Veolia Environnement SA
Sterling, VA
- $104,000 to $119,000 USD / year
Must have understanding of building mechanical systems design, construction & operation · Must have experience with commissioning process of mechanical systems ranging in size, rating and complexity
Added 1 hour ago
Manufacturing Design Engineer (MDE) - Watch
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Added 1 hour ago
Senior Project or Senior Environmental Geologist or Engineer
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California Professional Geologist (PG) or Professional Engineer (PE) license required · OSHA 40-hour HAZWOPER certification required
Added 1 hour ago
Senior Project or Senior Environmental Geologist or Engineer
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San Jose, CA
California Professional Geologist (PG) or Professional Engineer (PE) license required · OSHA 40-hour HAZWOPER certification required
Added 1 hour ago
Senior Project or Senior Environmental Geologist or Engineer
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California Professional Geologist (PG) or Professional Engineer (PE) license required · OSHA 40-hour HAZWOPER certification required
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California Professional Geologist (PG) or Professional Engineer (PE) license required · OSHA 40-hour HAZWOPER certification required
Added 1 hour ago
Project Manager - Water/Wastewater Engineering
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PMP (PMI), CCM or DBIA certification is required (within 12 months of hire or promotion onto the Approved Project Manager list)
Added 1 hour ago
Research Scientist/ Engineer 4, Fisheries Genomics
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Seattle, WA
The School of Aquatic and Fishery Sciences, SAFS, has an outstanding opportunity for a Research Scientist Engineer 4 to join their team. This is a permanent 1.0 FTE position.
Added 1 hour ago
Regulatory Affairs Engineer
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Hawthorne, CA
This Regulatory Affairs Engineer supports the Falcon, Dragon, and Starfall programs in FAA launch and reentry licensing and related regulatory affairs. The role demonstrates compliance with…
Added 1 hour ago
Staff SW QA Engineer
Dexcom
Remote, United States
You will influence project, product, and organizational decisions through expert risk-based quality assessments and recommendations.
Added 1 hour ago
Sr Systems Integration Engineer – Radiation Producing Subsystem
x Varian Medical Systems, Inc.
United States
We seek a versatile Systems Engineer for our Linear Accelerator Systems group, supporting radiation-producing subsystems in oncology machines. Responsibilities include contributing to…
Added 1 hour ago
Sr Staff CAD Engineer
MSI - (Marvell Semiconductor Inc.) US
Santa Clara, CA
Tool Evaluation and Selection: Evaluate and select third-party EDA tools, libraries, and IPs to meet project requirements, considering performance, scalability, and cost-effectiveness.

Nextern

Sr. Quality Assurance Engineer

Maple Grove, MN, United States

$100,000 to $140,000 USD / year

Apply on jobs.workable.com About employer

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Job details

Pay: $100,000 to $140,000 USD / year
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.

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

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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Jobs in the United States