Jobs in the United States

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Added 4 mins ago
Engineer 3, Test Automation C00253
CG
Elmhurst, IL
The Chamberlain Group LLC is looking for Design, develop, implement, maintain, and troubleshoot automated test systems and equipment for product validation and verification. Develop and…
Added 4 mins ago
IG
Software Controls Engineer
Insight Global
Aurora, CO
- From $55 USD / hour
Able to pass required background check and drug test
Added 4 mins ago
Tactical Data Link (TDL) / Interoperability Data Specialist
CACI, INC.-FEDERAL
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Experience: 5+ years of relevant technical experience in Tactical Data Links (TDL) and C4ISR testing/integration (equivalent to a Senior Systems Engineer or Test Director level).
Added 7 mins ago
3D-CFD-Senior Propulsion System Virtual Engineer – Combustion System
Stellantis
Auburn Hills, MI
The Senior Propulsion System Virtual Engineer is responsible for providing guidance to design teams. He/ She will be an integral part of the development team. The engineer is responsible…
Added 7 mins ago
Cybersecurity Engineer
IRC Trane Technologies Company LLC
Davidson, NC
The Security Engineer is responsible for managing, maintaining, configuring, and supporting security technologies that protect enterprise identities, endpoints, applications, and data.
Added 10 mins ago
Mechanical Design Engineer (R&D Engineer 2/3)
Los Alamos National Laboratory
Los Alamos, NM
AOT-MDE is seeking a strongly self-motivated Mechanical Engineer (R&D Engineer 2/3) to be a member of the Engineering Team.
Added 10 mins ago
Project Controls Engineer 3 (Project Controls 3)
Los Alamos National Laboratory
Los Alamos, NM
Added 10 mins ago
Engineering Technologist 3/4
Los Alamos National Laboratory
Los Alamos, NM
The Engineer Technologist supports a challenging and technically complex construction scope requiring consistent engineering services, timely engineering deliverables, and direct support to…
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R&D Engineer 1/2
Los Alamos National Laboratory
Los Alamos, NM
This position will be filled at either the R&D Engineer 1 or 2 level, depending on the skills of the selected candidate. Additional job responsibilities (outlined below) will be assigned if…
Added 10 mins ago
Production Liaison Engineer (R&D Engineer 4)
Los Alamos National Laboratory
Los Alamos, NM
This position will be filled at an R&D Engineer 4 level.
Added 10 mins ago
Program Manager 1
Los Alamos National Laboratory
Los Alamos, NM
…must demonstrate initiative, take direction from the GTS chief engineer as well as group management, and collaborate effectively with Weapons Facility…
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Project Controls Engineer 3 (Project Controls 3)
Los Alamos National Laboratory
Los Alamos, NM
This Project Controls Engineer 3 (PCE3)/Project Controls 3 position is within the Project Controls Division (PC-DO) and will be deployed into programs within the Weapons Directorate (DDW)…
Added 10 mins ago
Project Engineer Controls 4 (Project Controls 4)
Los Alamos National Laboratory
Los Alamos, NM
This Project Engineer Controls 4 (PCE4) position is a Project Controls Division position that provides leadership and oversight for a Project Controls team responsible for implementing LANL…
Added 10 mins ago
Test Engineer (R&D Engineer 3)
Los Alamos National Laboratory
Los Alamos, NM
Q-6 is offering an opportunity to join the Detonation Science and Technology Group as an R&D Engineer supporting High Consequence Experiments, including hydrodynamic tests funded by the Los…
Added 10 mins ago
Principal Mechanical Engineer
Leidos
Albuquerque, NM
The engineer will be responsible for taking mechanical designs from concept through detailed design, fabrication, assembly, integration, and test. The position requires an individual who…
Added 10 mins ago
Cleared R&D Systems Engineer - Interconnectivity and Verification, Onsite
Sandia National Laboratories
Albuquerque, NM
We are seeking an R&D Systems Engineer to support our dynamic group in the Mobile Guardian Transport Program Management and System Engineering group.
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Sr. Radiology Clinical Specialist (Current ARRT required) - West Coast
Medtronic
Albuquerque, NM
Maintain tools and test equipment properly and ensuring they are calibrated
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Cleared Senior/Principal R&D Systems Engineer ¿ System Security Engineering & Assurance, Onsite
Sandia National Laboratories
Albuquerque, NM
Sandia¿s Nuclear Enterprise Assurance (NEA) Team seeks a multidisciplinary R&D Systems Security Engineer to lead the secure product realization lifecycle for high-consequence national…
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Cleared Senior/Principal Mechanical Engineer - Component Engineer, Onsite
Sandia National Laboratories
Albuquerque, NM
We are seeking an exceptional mechanical engineer to support our ferroelectric neutron generator (FENG) products. As a component engineer you will serve in various roles, including…
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Cleared Senior/Principal R&D Systems Engineer - Interconnectivity and Verification, Onsite
Sandia National Laboratories
Albuquerque, NM
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Added 10 mins ago
Cleared Senior/Principal Systems Engineer - Space Systems, Onsite (Colorado Springs, CO)
Sandia National Laboratories
Albuquerque, NM
We are seeking a cleared, experienced Space Systems Engineer to be an on-site customer liaison that sits with the US Space Force customer in Colorado Springs, Colorado. The person occupying…
Added 10 mins ago
Senior/Principal RD Computer Engineer - LabVIEW Programmer, Onsite
Sandia National Laboratories
Albuquerque, NM
Organization 7588 is seeking an experienced Software Engineer to join our dynamic team. Our teams of engineers have a deep understanding of designing, building, and maintaining complex…
Added 10 mins ago
Sr Mechanical Engineer
Leidos
Albuquerque, NM
Leidos Defense Systems is seeking a highly motivated Sr Mechanical Engineer who loves collaboration and being a part of something big, to join our team. This role drives the implementation…
Added 10 mins ago
Cleared Senior/Principal R&D Mechanical Engineer - Targets, Countermeasures and Associated Objects (TCAO), Onsite
Sandia National Laboratories
Albuquerque, NM
The ideal R&D S&E Mechanical Engineer candidate for Sandia National Laboratories will in addition possess the following:
Added 10 mins ago
Mid-Early Career R&D Computer Aided Design and Drafting Technologist, Onsite
Sandia National Laboratories
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We are seeking a Computer Aided Design and Drafting Technologists to join our Design Engineer Group. In this role, you will be at the forefront of innovation, transforming customer concepts…

Jobgether

Quality Systems Manager

Remote, United States

Apply on jobs.lever.co About employer

Applications open in a new tab.

Job details

Experience: 5–10 years of experience in a medical device, pharmaceutical, biomedical, or other regulated quality environment.
Posting language: English
Posted: Nov 6, 2026

Original job description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Quality Systems Manager based in the United States.

The Quality Systems Manager will oversee and continuously improve the Quality Management System (QMS) supporting a regulated medical device environment. This role ensures that internal processes, product quality, and distribution activities meet applicable regulatory requirements and industry standards. You will work closely with cross-functional teams across Quality, Regulatory, Operations, Clinical, and external manufacturing partners to maintain compliance and strengthen quality performance. The position combines technical expertise, regulatory knowledge, and stakeholder leadership to identify risks and implement effective solutions. You will also lead audits, support regulatory inspections, and drive initiatives that improve organizational quality capabilities. This is an opportunity to make a meaningful contribution to the safety, reliability, and quality of medical technologies. Accountabilities

In this role, you will lead Quality Systems activities, support regulatory compliance, and promote continuous improvement across internal teams and external partners. Your responsibilities will include:

• Quality Management System Oversight: Manage Quality Systems activities in accordance with organizational policies and applicable medical device regulations and standards.

• Cross-Functional Collaboration: Serve as the primary Quality Systems contact for internal stakeholders, supporting coordination with corporate Quality, Regulatory, Operations, and Clinical teams.

• Physician Communications: Manage communications with physicians regarding returned product analysis test results.

• Product Quality and Distribution: Lead and support cross-functional teams to ensure product quality and distribution activities comply with regulatory requirements, industry standards, and internal procedures.

• Process Management and Improvement: Implement, maintain, and improve quality processes and procedures, including internal audits, change management, supplier quality, clinical research quality, complaint handling, and document control.

• External Partner Management: Manage external contract design and manufacturing organizations (CMDOs) in collaboration with the sourcing team.

• Performance Monitoring: Track departmental goals, metrics, and performance indicators to ensure quality objectives are achieved.

• Resource Planning: Support resource planning and provide input into departmental and organizational budgets and staffing requirements.

• Quality and Compliance Awareness: Promote understanding of regulatory, quality, and customer requirements throughout the organization.

• Risk Management: Identify and communicate potential quality and compliance risks, recommending appropriate corrective actions.

• Regulatory Compliance: Support the maintenance and improvement of compliance with FDA 21 CFR Part 820 Quality Management System Regulation (QMSR), ISO 13485, and other applicable requirements across internal and external sites.

• Audits and Inspections: Lead internal and external audits and support inspections conducted by regulatory agencies and notified bodies.

• Continuous Improvement: Drive initiatives to strengthen Quality Systems processes, compliance activities, and overall operational effectiveness.

Requirements

The ideal candidate will combine a solid technical background with practical experience in quality management within a regulated medical device, pharmaceutical, or biomedical environment. Strong analytical, communication, and influencing skills are essential, along with the ability to manage competing priorities. The qualifications include:

• Bachelor's degree in Engineering, Computer Science, Physics, Life Sciences, or a related technical field. An advanced degree is preferred.

• 5–10 years of experience in a medical device, pharmaceutical, biomedical, or other regulated quality environment.

• Experience supporting quality engineering activities within a regulated product environment.

• Strong understanding of risk management, supplier quality, complaint management, and Quality Management System requirements.

• Ability to communicate technical and regulatory requirements effectively across different organizational levels.

• Familiarity with configuration and change management practices.

• Demonstrated ability to influence cross-functional stakeholders and manage competing priorities.

• Strong analytical, organizational, and problem-solving skills.

• Excellent written and verbal communication skills.

• Working knowledge of FDA regulations, including 21 CFR Parts 11, 801, 803, 806, 807, 812, 820, 822, and 830.

• Working knowledge of ISO 13485 and medical device Quality Management Systems.

• Understanding of Good Manufacturing Practice (GMP) requirements.

• Knowledge of quality processes throughout the product lifecycle.

• Understanding of statistical methods and quality improvement tools.

• Strong engineering and technical aptitude across hardware, software, and systems development environments.

• Experience supporting regulatory submissions, audits, and inspections is preferred.

Nice to have:

• Experience participating in regulatory inspections and third-party audits.

• Relevant professional certification, such as ASQ Certified Quality Manager (CQM), Certified Quality Engineer (CQE), or equivalent.

• ISO 13485 Lead Auditor or ASQ Certified Quality Auditor (CQA) qualification.

Additional role details:

• No direct reports; the role leads cross-functional contributors through expertise and influence.

• Full-time position, Monday through Friday, with working hours potentially varying according to the time zones supported.

• Occasional evening or weekend work may be required depending on business needs.

• Limited, occasional travel for specific projects, meetings, or events.

• Primarily based in a professional office or remote office environment, with occasional participation in supplier-related activities and events.

• Requires regular mobility, frequent use of computers and mobile devices, and the ability to communicate and collaborate effectively over extended periods. Reasonable accommodations may be made for individuals with disabilities.

Benefits

• Work Arrangement: Remote position based out of Lake Oswego, Oregon.

• Employment Type: Full-time, permanent position.

• Working Schedule: Standard Monday-to-Friday schedule, with hours adapted to the time zones supported.

• Travel: Limited and occasional travel for assigned projects, meetings, or events.

• Equal Opportunity: All qualified applicants receive consideration without discrimination based on legally protected characteristics.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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More about this job

Skills

Quality control systems
Quality assurance procedures
Regulatory compliance
Leadership
Inspection
Process improvement
Manage footwear quality systems
Medical device regulations
Internal auditing
Change management
Clinical research
Risk management
Communication skills
Computer science
Problem solving
Good manufacturing practices

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Work requirements

Jobs in the United States