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Added 1 min ago
IT Security Operations (6152-1)
Tri-Force Consulting Services, Inc.
New York, NY
…Security Cloud Developer & Architect is responsible for designing, engineering, and modernizing enterprise identity governance capabilities across hybrid cloud and on prem environments.…
Added 3 mins ago
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Senior Preconstruction Manager
GPAC
St Louis, MO
- $125,000 to $150,000 USD / year
We are seeking a Senior Preconstruction Manager to lead preconstruction strategy, develop competitive project budgets, build strong client relationships, and collaborate with project teams…
Added 4 mins ago
HG
Senior Director - Technical Alliances
Hitachi Global
Remote, United States
- $275,000 to $350,000 USD / year
Lead a lean, experienced team; establish the capabilities, development priorities and hiring plan needed to deliver the future strategy.
Added 4 mins ago
J
Senior Machine Learning Engineer
Jobgether
Remote, United States
- $134,400 to $168,000 USD / year
…accurate, reliable customer experiences. In this role, you will lead the development of computer vision and multimodal models, taking innovative approaches from experimentation through…
Added 4 mins ago
IT Program Manager
Jobgether
Remote, United States
Lead, mentor, and develop program staff through performance management, career development, retention, and succession planning.
Added 4 mins ago
Director, Strategic Sales
Jobgether
Remote, United States
…opportunity to shape territory strategy, develop new markets, and lead complex six- and seven-figure software sales. You will engage directly with C-suite executives and senior security,…
Added 6 mins ago
G
Senior Preconstruction Manager
GPAC
Oregon City, OR
- $125,000 to $150,000 USD / year
We are seeking a Senior Preconstruction Manager to lead preconstruction strategy, develop competitive project budgets, build strong client relationships, and collaborate with project teams…
Added 6 mins ago
G
Senior Preconstruction Manager
GPAC
Albany, GA
- $125,000 to $150,000 USD / year
We are seeking a Senior Preconstruction Manager to lead preconstruction strategy, develop competitive project budgets, build strong client relationships, and collaborate with project teams…
Added 9 mins ago
Engineering Manager - Property Management
TheGuarantors
New York, NY
5+ years of software engineering experience, including experience leading a team as a Tech Lead, Tech Lead Manager, or Engineering Manager. A strong prior track record as a…
Added 9 mins ago
G
Senior Preconstruction Manager
GPAC
Dallas, TX
- $125,000 to $150,000 USD / year
We are seeking a Senior Preconstruction Manager to lead preconstruction strategy, develop competitive project budgets, build strong client relationships, and collaborate with project teams…
Added 9 mins ago
G
Senior Preconstruction Manager
GPAC
Fort Collins, CO
- $125,000 to $150,000 USD / year
We are seeking a Senior Preconstruction Manager to lead preconstruction strategy, develop competitive project budgets, build strong client relationships, and collaborate with project teams…
Added 9 mins ago
G
Senior Preconstruction Manager
GPAC
Livingston, NJ
- $125,000 to $150,000 USD / year
We are seeking a Senior Preconstruction Manager to lead preconstruction strategy, develop competitive project budgets, build strong client relationships, and collaborate with project teams…
Added 9 mins ago
G
Senior Preconstruction Manager
GPAC
Helena, MT
- $125,000 to $150,000 USD / year
We are seeking a Senior Preconstruction Manager to lead preconstruction strategy, develop competitive project budgets, build strong client relationships, and collaborate with project teams…
Added 9 mins ago
G
Senior Preconstruction Manager
GPAC
Richmond, VA
- $125,000 to $150,000 USD / year
We are seeking a Senior Preconstruction Manager to lead preconstruction strategy, develop competitive project budgets, build strong client relationships, and collaborate with project teams…
Added 9 mins ago
G
Senior Preconstruction Manager
GPAC
Walker, MI
- $125,000 to $150,000 USD / year
We are seeking a Senior Preconstruction Manager to lead preconstruction strategy, develop competitive project budgets, build strong client relationships, and collaborate with project teams…
Added 9 mins ago
G
Senior Preconstruction Manager
GPAC
Bowling Green, KY
- $125,000 to $150,000 USD / year
We are seeking a Senior Preconstruction Manager to lead preconstruction strategy, develop competitive project budgets, build strong client relationships, and collaborate with project teams…
Added 12 mins ago
Software Verification Engineer
NVIDIA Corporation
North District, IL
NVIDIA is looking for an outstanding Software Verification Engineer for our Linux Drivers group. You'll closely work with NVIDIA Driver developers, verification teams, and performance…
Added 12 mins ago
Senior Engineering Manager, Object Storage - DGX Cloud
NVIDIA Corporation
Remote, United States
…and training artifacts at scale. We are seeking a seasoned Engineering Manager to lead the Object Storage platform team with both dev and SRE responsibilities. You will own the full…
Added 15 mins ago
G
Project Manager Needed-Commercial Construction $10-40M
GPAC
Tulsa, OK
- $120,000 to $150,000 USD / year
Lead project teams, including contractors, subcontractors, and internal staff.
Added 15 mins ago
Senior Network Engineer, Google Enterprise Network
Google
Austin, TX · Thornton, CO
Lead the requirement analysis, engineering design, and development of solutions for Google’s Enterprise network infrastructure, executing new feature qualification, deployment, and…
Added 15 mins ago
G
Project Manager-Commercial Construction $10-40M
GPAC
Tulsa, OK
- $120,000 to $150,000 USD / year
Lead project teams, including contractors, subcontractors, and internal staff.
Added 15 mins ago
G
Project Manager Needed-Commercial Construction $10-40M
GPAC
Tulsa, OK
- $120,000 to $150,000 USD / year
Lead project teams, including contractors, subcontractors, and internal staff.
Added 15 mins ago
G
Project Manager-Commercial Construction $10-40M
GPAC
Raleigh, NC
- $120,000 to $135,000 USD / year
Lead project teams, including contractors, subcontractors, and internal staff.
Added 15 mins ago
G
Project Manager-Commercial Construction $10-40M
GPAC
Raleigh, NC
- $120,000 to $135,000 USD / year
Lead project teams, including contractors, subcontractors, and internal staff.
Added 15 mins ago
G
Project Manager Needed-Commercial Construction $10-40M
GPAC
Boise, ID
- $120,000 to $135,000 USD / year
Lead project teams, including contractors, subcontractors, and internal staff.

Nextern

Sr. Quality Assurance Engineer

Maple Grove, MN, United States

Salary range: $100,000 to $135,000 depending on skills and experience

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Job details

Pay: Salary range: $100,000 to $135,000 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

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.

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 $135,000 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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