Jobs in the United States

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Added 1 min ago
GM
Maintenance Technician - Solana at Duarte Station
Greystar Management Services, LLC
Duarte, CA
- $23 to $25 USD / hour
Incumbents must have EPA certifications Type 1 and II or Universal for refrigerant recycling · Incumbents must have all certifications as required by State and Local jurisdictions
Added 1 min ago
GM
Leasing Professional - Paramount at Cedar Lodge
Greystar Management Services, LLC
Baton Rouge, LA
- $14 to $16 USD / hour
Incumbents must have all licenses and/or certifications as required by State and Local jurisdictions · Incumbents must have valid driver’s license to operate a golf cart on property
Added 1 min ago
GM
Leasing Professional - The Monroe (CA)
Greystar Management Services, LLC
Monrovia, CA
- $22 to $24 USD / hour
Incumbents must have all licenses and/or certifications as required by State and Local jurisdictions · Incumbents must have valid driver’s license to operate a golf cart on property
Added 1 min ago
GM
Maintenance Supervisor - Museum Terrace
Greystar Management Services, LLC
Los Angeles, CA
- $33 to $35 USD / hour
Incumbents must have all certifications as required by State and Local jurisdictions · Incumbents must have a valid driver’s license to operate a golf cart on the property, if applicable
Added 1 min ago
Service Supervisor- Westlink at Oak Station-
Greystar Management Services, LLC
Lakewood, CO
Incumbents must have all certifications as required by State and Local jurisdictions · Incumbents must have a valid driver’s license to operate a golf cart on the property, if applicable
Added 1 min ago
General Manager
CHIPOTLE
Anderson, SC
Train and develop crew members, shift leaders, and Apprentices, utilizing Chipotle’s training tools and resources
Added 1 min ago
Assistant General Manager
CHIPOTLE
Ridgeland, MS
Train and develop crew members utilizing Chipotle’s training tools and resources
Added 2 mins ago
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United States
Monitor and analyze marketing performance using Salesforce, Tableau, and other reporting tools.
Added 2 mins ago
Engineer III - Technology
Edward Jones
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Louis, MO home office locations are expected to work in the office four days per week."
Added 3 mins ago
DC
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- $8,672.73 to $11,622.28 USD / month
Experience with business intelligence tools such as Power BI, Tableau, Power Query, or scripting languages such as SQL.
Added 3 mins ago
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Create and validate work orders with accurate details for labor, parts, and tools.
Added 4 mins ago
BC
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- $16 to $19 USD / hour
Use a variety of hand-held tools to detail the interior of RV's
Added 4 mins ago
Director, Human Resources
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Proficiency with Human Resource Information Systems (HRIS), applicant tracking systems, Microsoft Office Suite, and workforce analytics tools.
Added 4 mins ago
KC
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King County
Seattle, WA
- $77.35 to $93.51 USD / hour
Added 4 mins ago
KC
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Added 4 mins ago
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- $52.93 to $67.09 USD / hour
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Forensic Interviewer (Internal Applicants Only)
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Renton, WA · Kent, WA
- $52.93 to $67.09 USD / hour
Added 6 mins ago
CC
Registered Behavior Technician (RBT)/Behavior Technician
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Piscataway, NJ
- $20 to $30 USD / hour
We may use AI tools to support parts of the hiring process, but all final hiring decisions are made by humans. If you would like more information about how your data is processed, please…
Added 6 mins ago
Conference Associate
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Washington, DC
Added 6 mins ago
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Registered Behavior Technician (RBT) / Behavior Technician
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Jersey City, NJ
- $20 to $30 USD / hour
We may use AI tools to support parts of the hiring process, but all final hiring decisions are made by humans. If you would like more information about how your data is processed, please…
Added 7 mins ago
RT
Master Certified Technician | Flat-Rate - Tonkin Hillsboro Chevrolet
Ron Tonkin Chevrolet
Hillsboro, OR
- $10,000 to $15,000 USD / month
Must hold Master Technician Certification (ASE Master level preferred)
Added 7 mins ago
SG
Supplier Quality Engineer
Smiths Group
Morton Grove, IL
- $72,500 to $90,000 USD / year
Experience with quality tools such as FMEA, PPAP, Control Plans, Root Cause Analysis, Corrective Actions, Lean, Kaizen, and 5S.
Added 7 mins ago
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Conducts job analysis and contributes to the development and maintenance of competency-focused job descriptions, interview guides, rating documents, and candidate assessment tools.
Added 8 mins ago
RG
Data Engineering Intern - Summer 2027
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Los Angeles, CA
- $53.41 to $69.28 USD / hour
Riot’s Data Engineers build tools and data products that help teams understand and improve the experience of players worldwide. They work across data pipelines, data modeling, data…
Added 8 mins ago
Sr. Manager, Environmental Health and Safety
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Knowledge of quality tools such as lean manufacturing principles, statistical process control, root cause analysis and corrective action, process failure mode and effects analysis (PFMEA),…

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.

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

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Jobs in the United States