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Added 3 mins ago
Senior Security GRC Engineer, AI & Automation
American Express Global Business Travel
Jefferson City, MO
AmexGBT's Security GRC team is looking for a talented Senior Security GRC Engineer to design, build, and scale automation and AI-driven solutions that modernize our governance, risk, and…
Added 4 mins ago
Software Engineer 2 - Mobile Developer (iOS & Android)
U.S. Bank
Earth City, MO
+ Consistently creates optimal design adhering to architectural best practices; considers scalability, reliability, and performance of systems/contexts affected when defining technical…
Added 8 mins ago
Software Engineer, Machine Learning RecSys
Meta
Pierre, SD
Software Engineer, Machine Learning RecSys Responsibilities:
Added 8 mins ago
C
Java Full Stack Engineer with Spring boot/AWS Experience
Cognizant
Pierre, SD
- $86,000 to $99,000 USD / year
As a Java Full Stack Engineer with Spring boot/AWS exp, you will make an impact by designing and delivering scalable, cloud-native healthcare payer applications that improve payment…
Added 8 mins ago
C
Java Full Stack Engineer with Spring boot/AWS Experience
Cognizant
Pierre, SD
- $86,000 to $99,000 USD / year
As a Java Full Stack Engineer with Spring boot/AWS exp, you will make an impact by designing and delivering scalable, cloud-native healthcare payer applications that improve payment…
Added 8 mins ago
GA
Sr Staff Applications Operations Engineer – Engineering Tools Automation & AI Ops
GE Aerospace
Pierre, SD
- $131,000 to $174,000 USD / year
Experience leveraging AI-enabled operational tools and automation to streamline infrastructure support, reduce manual effort, and improve service reliability.
Added 8 mins ago
Lead Director Product Membership
CVS Health
Remote, United States
…proprietary HCD analytics platforms), ensuring high system reliability, data integrity, and real-time…
Added 8 mins ago
EG
Cloud Engineer
Eliassen Group
Pierre, SD
- $70 to $88 USD / hour
Our client seeks a senior Cloud Engineer to own and stabilize a legacy GCP and Azure footprint while assisting with conversions and decommissioning. The role will support automation efforts…
Added 11 mins ago
Senior Full Stack Developer, Agentic Engineering
FullBloom
Statewide, PA
This role is hired to build agent-first. The Senior Full-Stack Developer, Agentic Engineer is a founding member of a small, new engineering squad building the next generation of…
Added 21 mins ago
CT
Middleware Engineer – Software AG Stack
Computer Task Group, Inc
UNAVAILABLE
- $48 to $52 USD / hour
CTG is seeking to fill a Middleware Engineer – Software AG Stack position for our client.
Added 40 mins ago
G
Maintenance Engineer
GPAC
Minnetonka, MN
- $34 to $41 USD / hour
A global leader in food processing technology is seeking a Maintenance Engineer to join its technical applications team.
Added 40 mins ago
G
Maintenance Engineer
GPAC
New Hope, MN
- $34 to $41 USD / hour
A global leader in food processing technology is seeking a Maintenance Engineer to join its technical applications team.
Added 40 mins ago
G
Maintenance Engineer
GPAC
Eden Prairie, MN
- $34 to $41 USD / hour
A global leader in food processing technology is seeking a Maintenance Engineer to join its technical applications team.
Added 40 mins ago
G
Maintenance Engineer
GPAC
Hopkins, MN
- $34 to $41 USD / hour
A global leader in food processing technology is seeking a Maintenance Engineer to join its technical applications team.
Added 40 mins ago
G
Maintenance Engineer
GPAC
Champlin, MN
- $34 to $41 USD / hour
A global leader in food processing technology is seeking a Maintenance Engineer to join its technical applications team.
Added 40 mins ago
G
Maintenance Engineer
GPAC
St Louis Park, MN
- $34 to $41 USD / hour
A global leader in food processing technology is seeking a Maintenance Engineer to join its technical applications team.
Added 41 mins ago
G
Maintenance Engineer
GPAC
Wayzata, MN
- $34 to $41 USD / hour
A global leader in food processing technology is seeking a Maintenance Engineer to join its technical applications team.
Added 41 mins ago
G
Maintenance Engineer
GPAC
Mound, MN
- $34 to $41 USD / hour
A global leader in food processing technology is seeking a Maintenance Engineer to join its technical applications team.
Added 41 mins ago
G
Maintenance Engineer
GPAC
Shakopee, MN
- $34 to $41 USD / hour
A global leader in food processing technology is seeking a Maintenance Engineer to join its technical applications team.
Added 48 mins ago
M
Senior Machine Learning Engineer / Applied Scientist
Microsoft
BC, CA
- $114,400 to $203,900 CAD / year
We are looking for a Senior Machine Learning Engineer / Applied Scientist to help design, evaluate, and ship the next generation of AI-powered product experiences. The role combines strong…
Added 1 hour ago
EG
Cloud Engineer
Eliassen Group
Augusta, ME
- $70 to $88 USD / hour
Our client seeks a senior Cloud Engineer to own and stabilize a legacy GCP and Azure footprint while assisting with conversions and decommissioning. The role will support automation efforts…
Added 1 hour ago
EG
Cloud Engineer
Eliassen Group
Helena, MT
- $70 to $88 USD / hour
Our client seeks a senior Cloud Engineer to own and stabilize a legacy GCP and Azure footprint while assisting with conversions and decommissioning. The role will support automation efforts…
Added 1 hour ago
Process Engineer - Paper Machines
Smurfit Westrock
Hodge, LA
The Manufacturing Process Engineer, Paper Machines, supports the Paper Machines operations by safely improving processes and supporting the development, and implementation of new and/or…
Added 1 hour ago
Databricks Engineer
CGI Technologies and Solutions, Inc.
Lafayette, LA
We CGI is seeking an experienced Databricks Engineer to join our AI Cloud Engineering (ACE) Practice. Team members will deliver POCs, pilots, and production solutions while supporting…
Added 1 hour ago
EG
Cloud Engineer
Eliassen Group
Baton Rouge, LA
- $70 to $88 USD / hour
Our client seeks a senior Cloud Engineer to own and stabilize a legacy GCP and Azure footprint while assisting with conversions and decommissioning. The role will support automation efforts…

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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