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Added 2 mins ago
Mechanical/Robotics Engineering Technician I
Schweitzer Engineering Laboratories, Inc.
Pullman, WA
…environments safer, more reliable, and more economical. You'll use tools like collaborative/industrial robotics, end-of-arm tooling, computer vision tools, and self-developed mechanical…
Added 2 mins ago
G
Project Manager - Earthwork
GPAC
Pickerington, OH
- $90,000 to $150,000 USD / year
Lead estimating efforts using Agtek and other tools to prepare accurate takeoffs, bids, and cost models.
Added 3 mins ago
VH
Medical Support Assistant
Veterans Health Administration
San Diego, CA
- $40,177 to $65,597 USD / year
Added 3 mins ago
DF
COBOL DEVELOPER
Defense Finance and Accounting Service
Cleveland, OH · Columbus, OH · Indianapolis, IN
- $90,341 to $121,502 USD / year
…and configuring mainframe online application programs using tools such as CICS or…
Added 3 mins ago
NA
LOGISTICS MANAGEMENT SPECIALIST
Naval Air Systems Command
Patuxent River, MD
- $102,415 to $158,322 USD / year
…results from working with process improvement initiatives and tools. | You will facilitate organizational, intermediate, and depot level review through tracking and reporting on the status…
Added 3 mins ago
UA
LOCK AND DAM OPERATOR
U.S. Army Corps of Engineers
Troy, NY
- $31 to $36 USD / hour
…areas, from falling objects, from working with electrical power tools and wiring or other equipment, from working with normal manual tools and from falls while working on lock walls, dam…
Added 3 mins ago
NA
SUPERVISORY INTERNATIONAL FINANCIAL MANAGEMENT ANALYST
Naval Air Systems Command
Patuxent River, MD
- $143,913 to $197,200 USD / year
This recruitment will utilize the following technical assessment tools: Structured Resume Review, Structured Interview
Added 3 mins ago
NF
ENVIRONMENTAL ENGINEER/PHYSICAL SCIENTIST
Naval Facilities Engineering Systems Command
Bangor, WA
- $119,630 to $155,521 USD / year
Added 3 mins ago
BO
SUPERVISORY ENGINEERING TECHNICIAN
Bureau of Naval Personnel
Annapolis, MD
- $102,415 to $133,142 USD / year
This recruitment will utilize the following technical assessment tools: Structured Resume Review, Structured Interview.
Added 3 mins ago
SO
PROGRAM ANALYST
Secretary of the Navy Offices (SECNAV)
Washington Navy Yard, DC
- $102,415 to $158,322 USD / year
Experience utilizing basic office computer software to perform review, analytics and document preparation using IT tools such as MS Excel, Power Point, Word or similar software/database…
Added 3 mins ago
NA
SUPERVISORY ELECTRONICS ENGINEER
Naval Air Systems Command
Jacksonville, FL
- $125,776 to $163,514 USD / year
Added 3 mins ago
NA
General Engineer
Naval Air Systems Command
Jacksonville, FL
- $106,437 to $138,370 USD / year
Added 3 mins ago
AA
Resource Management Specialist
Animal and Plant Health Inspection Service
Location Negotiable After Selection
- $89,508 to $130,786 USD / year
…when the review was performed. | Provide guidance and tracking tools for Within Grade Increases (WGI), Career Ladder Promotions, and the like for monitoring and implementation in a timely…
Added 3 mins ago
NA
AEROSPACE ENGINEER
Naval Air Systems Command
Tinker AFB, OK · Fort Worth, TX · Jacksonville, FL
- $125,776 to $163,514 USD / year
Added 3 mins ago
VH
Occupational Therapist - Inpatient PRC/CRC Float
Veterans Health Administration
Palo Alto, CA
- $102,818 to $193,838 USD / year
Evaluates patients' Occupational Profile, abilities, and functional limitations using standardized tools; develops individualized treatment plans based on evaluation findings, OT theory,…
Added 3 mins ago
CA
PROGRAM MANAGER
Customs and Border Protection
Washington, DC
- $143,913 to $187,093 USD / year
Applying advanced analytical tools and methodologies (e.g., statistical analysis, program evaluation techniques) to resolve broad and complex management or resource allocation problems for…
Added 3 mins ago
G
Project Manager - Earthwork
GPAC
Columbus, OH
- $90,000 to $150,000 USD / year
Lead estimating efforts using Agtek and other tools to prepare accurate takeoffs, bids, and cost models.
Added 3 mins ago
VH
Supervisory Orthotist/Prosthetist
Veterans Health Administration
Honolulu, HI
- $93,445 to $121,482 USD / year
Added 3 mins ago
VH
Medical Technician
Veterans Health Administration
Corpus Christi, TX
- $45,235 to $59,318 USD / year
Added 3 mins ago
KC
Training and Professional Development Lead, Educator Consultant III
King County
Seattle, WA
- $107,507.3 to $136,271.62 USD / year
Work with leaders to understand how changes affect employees and identify the tools, resources, and support teams need.
Added 3 mins ago
KC
Business Finance Officer II
King County
Seattle, WA
- $47.01 to $59.59 USD / hour
King County has a robust collection of tools and resources to support working remotely. The individual selected for this opportunity will join an innovative and progressive team that is…
Added 5 mins ago
Product Manager II
Google
New York, NY · Mountain View, CA
Experience integrating generative AI tools or LLM interfaces into workflows.
Added 5 mins ago
Business Operations Principal, Core
Google
San Jose, CA · San Francisco, CA · New York, NY
Experience with R, SQL, spreadsheets, or similar analytics tools.
Added 5 mins ago
Security Sales Specialist II, User Protection Services, Google Cloud
Google
San Francisco, CA · Irvine, CA · Los Angeles, CA · Seattle, WA
…solutions that leverage Google’s cutting-edge technology, and tools that help developers build more sustainably. Customers in more than 200 countries and territories turn to Google Cloud as…
Added 7 mins ago
G
Project Manager - Earthwork
GPAC
Elk River, MN
- $90,000 to $150,000 USD / year
Lead estimating efforts using Agtek and other tools to prepare accurate takeoffs, bids, and cost models.

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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