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Added 1 min ago
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Power Platform Developer
TEKsystems
Charlotte, NC
- $55 to $65 USD / hour
…NC.TEKsystems is currently looking for a Power Platform Solution Engineer specializing in the conversion and modernization of legacy forms and workflows. This individual will serve as the…
Added 2 mins ago
Principal Controls Engineer
Baxter Healthcare Corporation
Marion, NC
Your talent is needed across a wide variety of industries. As a Principal Controls Engineer, you have a wide array of career choices, but are motivated by the opportunity to work in a…
Added 2 mins ago
Senior Controls Engineer
Baxter Healthcare Corporation
Marion, NC
Performs engineering studies on new equipment to resolve accurate settings, control points, etc. including data collecting during start up and test batches.
Added 3 mins ago
Senior Snowflake Data Engineer
Strategic Staffing Solutions
San Antonio, TX
“Beware of scams. S3 never asks for money during its onboarding process.”
Added 3 mins ago
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QA/QC Field Engineer/ Inspector- Federal Facilities
Turner & Townsend
Oakland, CA
- $110,000 to $145,000 USD / year
Turner & Townsend Heery is seeking a QA/QC Field Engineer/Inspector to provide field observation, quality assurance, and construction compliance services for a major occupied federal…
Added 3 mins ago
Software Project Engineer
Duravant
Waukesha, WI
Pyramid - a Duravant Company, is a leading provider of Warehouse Execution and Warehouse Control Systems, controls integration, and fulfillment technologies, including pick-to-light…
Added 3 mins ago
Electrical Systems & Wiring Harness Engineer
Tige Boats
Abilene, TX
Electrical Systems & Wiring Harness Engineer Location: Abilene, Texas
Added 4 mins ago
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Full Stack Quality Assurance Engineer
Automated Logic Corporation
Kennesaw, GA
- $79,000 to $158,000 USD / year
We are seeking an experienced Full Stack Software Quality Assurance Engineer to ensure software and firmware quality, reliability, and performance through system-level, regression, and…
Added 5 mins ago
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Test Engineer I (58338)
ATS FAMILY
COLORADO SPRINGS, CO
- $70,000 to $80,000 USD / year
…collected solely for purposes of complying with U.S. export control requirements and will not be used to unlawfully discriminate in the hiring…
Added 7 mins ago
Controls Software Engineer
Insight Global
Dunwoody, GA
Insight Global is seeking a Controls Software Engineer to support a hyperscale data center program. This role will be based out of our corporate headquarters in Atlanta, GA in order to work…
Added 7 mins ago
Field Welding Engineer / NDE Coordinator
Bechtel
Thacker Pass, NV
Planned with sustainability and the environment in mind, the facility will use its excess process heat to generate electricity and will recycle process water up to seven times. Once the…
Added 7 mins ago
Network Security Engineer
Georgia Systems Operations
Tucker, GA
Engineer and operate secure web and DNS controls, network detection and response, security logging, SIEM integrations, and security-control health monitoring.
Added 7 mins ago
Senior Logistics Specialist
Leidos
Warner Robins, GA
…global depot level logistics sustainment support for Command and Control, Intelligence, Surveillance, and Reconnaissance (C2ISR)…
Added 7 mins ago
Associate Manufacturing Test Engineer (2nd shift)
Carrier
Kennesaw, GA
The Associate Manufacturing Test Engineer will create the roadmap for the entire production test environment and develop implementation strategies. The primary roles and responsibilities of…
Added 7 mins ago
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Physical Security Engineer
TEKsystems
Alpharetta, GA
- $55 to $65 USD / hour
This role supports global physical security technology infrastructure for LexisNexis Risk, a division of RELX. The engineer will administer and maintain enterprise access control systems,…
Added 7 mins ago
Substation Protection and Controls Engineer - (South)
Leidos
Atlanta, GA
We are looking for a Substation Protection & Control Engineer to join our team in our Substation South Group. As a Protection & Control Engineer, candidates will have the opportunity to…
Added 7 mins ago
Substation Physical Engineer - (South)
Leidos
Atlanta, GA
We are looking for a Substation Physical Engineer to join our team. As an Career Substation Physical Engineer, candidates will have the opportunity to work on projects for electric…
Added 7 mins ago
Substation Protection and Controls Engineer - (South)
Leidos
Atlanta, GA
We are looking for a Substation Protection & Control Engineer to join our team in our Substation South Group. As a Protection & Control Engineer, candidates will have the opportunity to…
Added 7 mins ago
Substation Physical Engineer - (South)
Leidos
Atlanta, GA
We are looking for a Substation Physical Engineer to join our team. As an Career Substation Physical Engineer, candidates will have the opportunity to work on projects for electric…
Added 7 mins ago
Automation Engineer 4 (SDET/API automation)
U.S. Bank
Atlanta, GA
The Automation Engineer tests, creates, implements and desktop automations. Performs design, scripting, testing, implementing, maintaining and modifying automations of moderate complexity,…
Added 8 mins ago
Sr. Quality Assurance Engineer
Nextern
Maple Grove, MN
Support line clearances, first-article inspections, and process change reviews.
Added 8 mins ago
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Senior Database Site Reliability Engineer – Oracle Database and GoldenGate (IC3)
Oracle
Atlanta, GA
- $81,100 to $187,000 USD / year
Oracle Health Database Services is seeking a highly experienced, Site Reliability Engineer to lead database reliability engineering across mission-critical healthcare platforms.
Added 8 mins ago
Senior AWS Cloud Engineer
Serco
Atlanta, GA
Looking for a Senior Cloud Engineer opportunity in an environment where you can make an impact every day? Discover this great opportunity with the Center for Medicare and Medicaid Services…
Added 8 mins ago
Systems Design Project Engineer
UPS
ATLANTA, GA
…adherence to contract documentation, scheduled timelines, and cost control parameters. This position may develop project documentation (e. g. , Request for Appropriation project scope of…
Added 8 mins ago
Advanced Lead Supplier Quality Engineer - Composites
GE Aerospace
Atlanta, GA
The Supplier Quality Engineer for Polymer Matrix Composites is an individual who can apply knowledge of RCCA and/or problem solving to lead supplier quality improvement of complex cross…

Nextern

Sr. Quality Assurance Engineer

Maple Grove, MN, United States

Salary range: $100,000 to $125,000 depending on skills and experience

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Job details

Pay: Salary range: $100,000 to $125,000 depending on skills and experience
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

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.

Requirements

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 $125,000 depending 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
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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