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Added 2 mins ago
Chief Engineer, CLT102
Amazon
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INTERDISCIPLINARY (MECHANICAL/AEROSPACE) ENGINEER
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Manufacturing Specialist
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Sr Materials Controller - BESS - NC Job Details | Black & Veatch Family of Companies
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Full Stack Senior Software Engineer (DevOps Focus)
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Instrumentation & Controls Engineer SME – Hyperscale Data Centers
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Data Scientist
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Software Engineer, Senior
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…conferring with users; studying systems flow, design, architecture, data usage, and work processes; investigating problem areas; following the software development…
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Integrate data, usability studies, research, and market analysis into product strategies and requirements to enhance user satisfaction and improve engineer productivity.
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Software Engineer (IBM Cognos)
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This job is an integral member of an agile software engineer team responsible for building complex scalable software applications across all digital channels to serve our customers. The…
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Lead Director - Security Operations Center (SOC)
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…position helps protect critical business operations, sensitive data, and customer…
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Senior Director Software Engineering
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Geotechnical Engineer II
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- $80,000 to $100,000 USD / year
Geotechnical Engineer II (Hybrid Flexibility)Grow Your Career with a Team That Invests in Engineers
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Distribution Engineer (Raleigh)
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- $27 to $30 USD / hour
We are seeking a motivated and detail-oriented Entry-Level Power Distribution Engineer to join a dynamic engineering team. This role is ideal for individuals with an engineering degree who…
Added 3 mins ago
Senior System Development Engineer - AWS Networking System Test, Release Engineering and System Test
Amazon
Raleigh, NC
…technologies. We're looking for a Senior System Development Engineer to develop automated test systems for the networking products that form the building blocks of Amazon's cloud…
Added 3 mins ago
Technical Engineer
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Raleigh, NC
Technical Proficiency: Comfortable with a range of data tools and technologies, with a willingness to learn new skills as needed
Added 3 mins ago
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Server Tech Services Engineer II
Akamai Technologies, Inc.
Raleigh, NC
- $76,100 to $136,900 USD / year
As a Server Tech Services Engineer II, you will serve as a key technical leader. You will resolve high-severity hardware and network issues across Akamai's infrastructure. In this role, you…
Added 3 mins ago
EC
Senior Testing Engineer
Eaton Corporation
Raleigh, NC
- $86,000 to $126,000 USD / year
Eaton’s Electrical division is currently seeking a Senior Testing Engineer.

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