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Added 1 min ago
Senior Mechanical Systems Engineer
KLA Corporation
Milpitas, CA
…subsystems from concept through production, making critical system-level decisions and influencing future platform architectures. You will work across mechanical, electrical, controls,…
Added 7 mins ago
Senior Software Engineer, Cloud Platform
Nvidia
Remote, United States
…provisioning to build a multi-tenant infrastructure. As a software engineer, you will work with other software engineers, product architects, and product managers as a collaborative team to…
Added 7 mins ago
Applications Engineer II IS -Remote
Providence
CA
The Application Engineer II is responsible for design, configuration, testing, implementation, and ongoing support of moderately complex applications and services. This role operates with…
Added 8 mins ago
Senior AI Engineer
MiniMed
CA
MiniMed is building a lean, high-leverage AI & Data Science team. We are looking for a Senior AI Engineer who builds AI capabilities hands-on and sets the standard the rest of the team…
Added 8 mins ago
Project Engineer I/II
Marathon Petroleum Corporation
La Palma, CA
L&SE is seeking a Project Engineer for our Pipeline Integrity Engineering team. The project engineer manages and is responsible for all aspects of assigned projects including project scope,…
Added 8 mins ago
Nobel Biocare Quality Engineer, Manufacturing (On-Site Yorba Linda, CA)
Envista Holdings Corporation
Yorba Linda, CA
The Quality Assurance Engineer is responsible to ensure that production processes remain in a state of control, validation and verification activities are robust, and processes consistently…
Added 8 mins ago
Senior Development Quality Engineer
Abbott
Sylmar, CA
The Senior Development Quality Engineer assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a…
Added 8 mins ago
M
Overnight Engineer II
Marriott
Burlingame, CA
- $58.61 USD / hour
…cleanup of the painting or repair area. Use the Lockout/Tagout system before performing any maintenance work. Display working knowledge of all engineering computer programs related to…
Added 8 mins ago
Lead Director Product Membership
CVS Health
Remote, United States
…Development Engineers, Data Engineers, Salesforce Analysts, and System Administrators) focused on building, scaling, and optimizing the technology that powers CVS Healthcare Delivery (HCD)…
Added 8 mins ago
Software Quality Engineer I
Abbott
Sylmar, CA
The Software Quality Engineer I provides design quality engineering support for the development and maintenance of mobile medical device software applications and connected digital health…
Added 8 mins ago
TT
Founding Engineer
True Talent Solutions Partners
New York, NY
- $160,000 to $200,000 USD / year
Join an early-stage healthtech team as its third engineer, working closely with the founders. You will help support and improve AI-powered clinical conversation simulations used in…
Added 8 mins ago
TT
Senior ML / AI Engineer
True Talent Solutions Partners
San Francisco, CA
- $200,000 to $300,000 USD / year
- Establish strong practices for ML development and system quality across the team.
Added 8 mins ago
A
Computer Engineer
Alluvionic
Port Hueneme, CA
- $105,010 to $122,837 USD / year
Alluvionic is seeking an experienced Computer Engineer to support the Naval Surface Warfare Center, Port Hueneme Division. This position contributes to the design, development, testing, and…
Added 8 mins ago
Civil Engineer
County of Santa Cruz
Santa Cruz, CA
…Roads Design position, we are looking for a Transportation Engineer to prepare and oversee engineering designs, plans and specifications for the construction of roadway improvement projects…
Added 8 mins ago
Staff Engineer, YouTube Shorts Creation Editor, Android
Google
San Bruno, CA
…including information retrieval, distributed computing, large-scale system design, networking and data storage, security, artificial intelligence, natural language processing, UI design and…
Added 8 mins ago
Senior Automation Engineer
C&W Services
Rialto, CA
As a Senior Automation Engineer (SAE), you will manage the Automation Engineering (AE) team at your facility. This includes coordinating the maintenance of the control systems, scheduling…
Added 8 mins ago
Automation Engineer Manager
C&W Services
Rancho Cordova, CA
As the Automation Engineer Manager, you will lead a team in driving equipment reliability and operational excellence across our fulfillment centers. You’ll monitor and support their work in…
Added 8 mins ago
Lead Planning & Optimization Advisor/Engineer
Marathon Petroleum Corporation
Carson, CA · Martinez, CA · Wilmington, CA
…including PIMS, the Cross-Regional Planning & Optimization Engineer evaluates scenarios, validates plans, and identifies opportunities to improve value capture across the system. They…
Added 8 mins ago
Electrical Engineer, Amazon Leo Government, Amazon Leo Government
Amazon
Northridge, CA
The Electrical Engineer will focus on satellite and ground system design and analysis of electronic components, circuits, and sub-systems. They will be expected to execute a variety of…
Added 8 mins ago
Transmission Engineering Manager
Southern California Edison
Pomona, CA
Develops and maintains a project portfolio management system to prioritize projects, allocate resources, and monitor performance.
Added 8 mins ago
Early Career R&D Mechanical Engineer - National Security Products Center, NM/CA, Onsite
Sandia National Laboratories
Livermore, CA
…qualification, deployment, production support, and fielded-system…
Added 8 mins ago
Clinical Specialist CRM - Burbank / Sherman Oaks
Medtronic
Burbank, CA
Provide technical support for CRM devices and therapies by performing system checks/interrogations, supporting implants, troubleshooting issues, and applying knowledge gained through…
Added 8 mins ago
DE
Staff Machine Learning Engineer
Disney Entertainment
Burbank, CA
- $158,100 to $211,900 USD / year
The Staff Machine Learning Engineer is part of the Creative Technology Platform organization within Studio Technology. This role leads applied deep learning work in computer vision and…
Added 8 mins ago
IT Infrastructure Engineer VI, Security
Kaiser Permanente
Pleasanton, CA
The Chief Engineer provides technical leadership for CyberArk Privileged Access Management (PAM), enterprise identity security, and privileged account governance. The position supports the…
Added 9 mins ago
Senior Production Site Reliability Engineer - PH
Disney Entertainment
Glendale, CA
…Technology team as a Senior Production Systems Reliability Engineer. In this role, you will develop and support cloud solutions for DKF productions and…

Jobgether

Quality Systems Manager

Remote, United States

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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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