Jobs in the United States

25+ jobs

Group jobs by employerEmail me new jobs Save this search

Added 24 mins ago
Digital Engineer
MANTECH
Remote, United States
8+ years as a system engineer, data engineer or software developer or other related areas such as experience in software engineering, full-stack application development, or AI/ML systems…
Added 51 mins ago
Information Systems Security Engineer
The Aerospace Corporation
Colorado Springs, CO
The Aerospace Corporation is the trusted partner to the nation’s space programs, solving the hardest problems and providing unmatched technical expertise. As the operator of a federally…
Added 1 hour ago
RF Device Engineer
The Aerospace Corporation
El Segundo, CA
…accelerating, and analyzing, failures in electronics used for space system. MTD is comprised of two sections: one that performs radiation effects testing and discrete microelectronics…
Added 1 hour ago
T
Value Engineering Manager
Tanium
Remote, United States
- $126,000 to $193,000 USD / year
…sales professionals. If you have experience working as a Value Engineer with a track record of successfully partnering with account teams, we would love to hear from…
Added 1 hour 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 1 hour 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 1 hour ago
N
Sr. Quality Assurance Engineer
Nextern
Maple Grove, MN
- $100,000 to $140,000 USD / year
This role is responsible for operational quality input and deliverables for manufacturing programs throughout the product lifecycle. Quality Assurance Engineers will also support…
Added 2 hours ago
Senior Systems Engineer - MANTIS SEIT (Onsite)
RTX
United States
Qualifications You Must Have
Added 2 hours ago
Systems Engineer
BAE Systems
Nashua, NH · Manchester, NH
Job Description Thank you for your interest in BAE Systems! Are you a Systems Engineer with 2 to 20+ years of experience looking for the next step to grow your career? Do you want to…
Added 2 hours ago
Program Management Manager
Swagelok Company
Solon
Lead the enterprise program responsible for strengthening quality, risk management, operational capability, and continuous improvement across Swagelok’s domestic and international sales and…
Added 3 hours ago
XS
Senior Cybersecurity Engineer
Xona Space Systems
Burlingame, CA
- $180,000 to $210,000 USD / year
Xona Space is seeking a Senior Cybersecurity Engineer to lead the development and implementation of our cybersecurity and compliance programs. This role will play a key part in…
Added 3 hours ago
Advanced Packaging Development Engineer
Apple
Santa Clara, CA
Apple’s Advanced Packaging team is seeking an experienced Packaging Development Engineer to drive next-generation packaging integration and technology development for future products. In…
Added 3 hours ago
RF Design Engineer – Next-Gen Wireless
Apple
San Diego, CA
technical culture as it grows. We're looking for an experienced engineer with strong
Added 3 hours ago
Mechanical Product Design Engineer III
Detroit Diesel Corporation
Detroit, MI
Hybrid (4 days per week in-office / 1 day remote)
Added 3 hours ago
Mechanical Engineer III - Tank Qualification Lead
Quantum Space
CA · Hawthorne, CA · 801 Thompson Ave. Suite 201 Rockville, MD
We are seeking an experienced and technically accomplished Mechanical Engineer III – Tank Qualification Lead to lead the design, development, qualification, and acceptance of spacecraft…
Added 3 hours ago
Senior Systems Engineer
The Mitre Corporation
Huntsville, AL
Must be based in Huntsville, AL or able to relocate to Huntsville · Must have an active Secret U.S Government issued Security Clearance
Added 3 hours ago
Manager Electronics Engineering 3
Northrop Grumman
San Diego
The successful candidate will have personally executed hardware and electrical engineering activities as an engineer and led teams of hardware engineers, while operating as a…
Added 3 hours ago
Senior Staff Radar Modeling Simulation & Analysis Systems Engineer
Northrop Grumman
Baltimore
Northrop Grumman Mission System’s Engineering and Sciences (E&S) Baltimore and Partnered Sites (BaPs) Division is seeking a Senior Staff Radar Modeling Simulation & Analysis Systems…
Added 3 hours ago
Staff Engineer Systems
Northrop Grumman
McLean
Must have U.S
Added 3 hours ago
Software Development Engineer, US Amazon Dedicated Cloud Security
Amazon.com Services LLC
Herndon, VA
…automation in support of Amazon Dedicated Clouds (ADCs) and Cleared…
Added 3 hours ago
Software Development Engineer, US Amazon Dedicated Cloud Security
Amazon.com Services LLC
Herndon, VA
…automation in support of Amazon Dedicated Clouds (ADCs) and Cleared…
Added 3 hours ago
Test Program Manager, Autonomous Airpower
Anduril Industries
Costa Mesa, CA
…for the FQ-44 Fury program. As Test Program Manager, you will lead the test and evaluation team alongside the Lead Test Engineer to conduct hardware-in-the-loop, software-in-the-loop,…
Added 3 hours ago
Systems Engineering Program Manager, Autonomous Airpower
Anduril Industries
Costa Mesa, CA
…mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century’s most innovative…
Added 4 hours ago
Design Services Principal Engineer
Theragenics Corp
North Attleboro, MA
The Principal Research and Development Engineer is a senior technical and hands-on role responsible for solving complex engineering problems and creating advanced research, modeling,…
Added 4 hours ago
Fabrication Buyer Planner
Victaulic Company
Justin, TX
Victaulic, headquartered in Easton, Pennsylvania, is the global leader in mechanical pipe joining solutions, delivering advanced technologies and engineering services to address complex…

Nextern

Sr. Quality Assurance Engineer

Maple Grove, MN, United States

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

Apply on jobs.workable.com About employer

Applications open in a new tab.

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.

Apply on jobs.workable.com About employer

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

Report this job

Work requirements

Jobs in the United States