Jobs in the United States

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Added 2 mins ago
Senior Cloud Developer
Hewlett Packard Enterprise
Ft. Collins, CO · Andover, MA
This role has been designed as 'Hybrid' with a requirement that you will work on average 2 days per week from an HPE office
Added 2 mins ago
Federal Principal Product Support Engineer, (Clearance Required - Secret), Oklahoma City, OK, Dallas or Houston, TX or Montgomery, AL
Hewlett Packard Enterprise
All, OK · All, TX
Role nature: This is a senior field-engineering position, not a traditional support or escalation-management role. You will work hands-on across the full infrastructure stack - from bare…
Added 3 mins ago
Senior Cloud Developer
Hewlett Packard Enterprise
Ft. Collins, CO · Andover, MA
This role has been designed as 'Hybrid' with a requirement that you will work on average 2 days per week from an HPE office
Added 3 mins ago
Federal Principal Product Support Engineer, (Clearance Required - Secret), Oklahoma City, OK, Dallas or Houston, TX or Montgomery, AL
Hewlett Packard Enterprise
All, OK · All, TX
Role nature: This is a senior field-engineering position, not a traditional support or escalation-management role. You will work hands-on across the full infrastructure stack - from bare…
Added 9 mins ago
Senior Turbomachinery Aerodynamic Engineer
Air Products and Chemical
Bethlehem, PA · Houston, TX
This position follows a hybrid work arrangement with four days per week in the office and requires minimal travel, typically less than 10%
Added 14 mins ago
Windows Systems Engineer, Region Services Corporate Infrastructure (Vector) Team
Amazon Development Center U.S., Inc.
Herndon, VA
We are looking for a Windows Systems Engineer who knows Windows infrastructure and is ready to transform how we manage it. Our direction is Infrastructure as Code - we need someone who can…
Added 16 mins ago
SCADA and PLC Service Technician
Faith Technologies, Inc.
El Paso, TX · Atlanta, GA · Opelika, AL · Tampa, FL · Montgomery, AL · Monroe, LA
We are seeking a highly skilled and motivated controls-oriented Application Engineer to join our team. The successful candidate will be responsible for providing technical support and…
Added 17 mins ago
RF Device Engineer
The Aerospace Corporation
El Segundo, CA
Physical Sciences Laboratories (PSL) support the effective and timely development and operation of national security systems through scientific research and the application of advanced…
Added 19 mins ago
CO
2027 Optics/Photonic Engineering Intern - Apopka FL
CORP-Corporate Office
United States
- $18.5 to $41.5 USD / hour
…in what you’ve done. Join us and launch your career. We’ll support you with training, professional development and networking opportunities, and our shared vision of global…
Added 19 mins ago
Embedded Software Engineer-Level 3/4 (AHT)
DS - Advanced Weapons - Northridge
United States
Northrop Grumman’s Defense System's, Advanced Weapons Division is looking for an Embedded Software Engineer-Level 3/4, located in Northridge, CA. This role will be 100% on-site with no…
Added 19 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 23 mins ago
SF
Assistant Chief Maintenance Officer
San Francisco Bay Area Rapid Transit District (BART)
Oakland, CA
- $94.71 to $143.48 USD / hour
…right-of-way assets are maintained and managed effectively to support safe, reliable, and efficient revenue service throughout the…
Added 34 mins ago
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Sr. Data Engineer (Python, Pyspark, AWS)
Randstad USA
Charlotte, NC
- $60 to $65 USD / hour
We are seeking a highly skilled Senior Data Engineer to join an innovative technology-driven team. This is an exceptional opportunity to enhance your career within the Data and Analytics…
Added 35 mins ago
SI
Software Engineering LMTS
Salesforce, Inc.
CA · IN · TX
- $172,500 to $285,800 USD / year
As a Lead Software Engineer, you will shape the technical direction of systems supporting Salesforce’s global finance operations. You will work across ERP capabilities, cloud services,…
Added 35 mins ago
Software Engineering LMTS
Salesforce, Inc.
TX · IN
As a Lead Software Engineer, you will drive the design and delivery of enterprise finance solutions that power Salesforce globally. You will work across ERP applications, APIs,…
Added 43 mins ago
KC
Electrical Engineering Supervisor
King County
Seattle, WA
- $77.35 to $93.51 USD / hour
Beyond electrification, the Capital Division ensures that Metro’s facilities remain safe, efficient, and ready to support daily operations. Through ongoing maintenance, upgrades, and…
Added 49 mins ago
N
Sr. Quality Assurance Engineer
Nextern
Maple Grove, MN
- $100,000 to $140,000 USD / year
…the product lifecycle. Quality Assurance Engineers will also support development activities as they prepare to launch into commercial manufacturing, such as manufacturing readiness, audits,…
Added 49 mins ago
N
Principal Quality Assurance Engineer
Nextern
Maple Grove, MN
- $130,000 to $170,000 USD / year
…engineering functions are responsible for compliance with the Quality System and relevant regulations and standards, continuous improvement, and as needed, professional interaction with…
Added 49 mins ago
N
Global Sr. Quality Assurance Engineer
Nextern
Maple Grove, MN
- $100,000 to $140,000 USD / year
…engineering functions are responsible for compliance with the Quality System and relevant regulations and standards, continuous improvement, and as needed, professional interaction with…
Added 49 mins ago
Sr Software Engineer, AWS Applied AI Solution – Core Services
Amazon Development Center U.S., Inc.
Seattle, WA
Added 55 mins ago
O
Senior Platform Software Engineer
Oracle
Nashville, TN
- $87,800 to $209,500 USD / year
Software Engineer - OCI User Experience Engineering Platform
Added 1 hour ago
Customer Service Engineer (VA ESOM IRP)
Kentro
Bedford, MA
Must have experience conducting routine system administration tasks and logging data in system admin logs
Added 1 hour ago
Customer Service Engineer (VA ESOM)
Kentro
Cincinnati, OH
Must have experience conducting routine system administration tasks and logging data in system admin logs
Added 1 hour ago
Systems Engineer I
Panasonic
De Soto, KS
The Systems Engineer I supports the design, implementation, and maintenance of systems and infrastructure that enable manufacturing and operational processes within a battery production…
Added 1 hour ago
Quality Engineering Technician I (Day shift)
Panasonic
Sparks, NV
Quality Engineering Technician I (Day Shift) · Must have working-level knowledge of the English language, including reading, writing, and speaking English

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