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Added 11 mins ago
ENGINEERING TECHNICIAN (CIVIL)
Air Combat Command
Moody AFB, GA
Summary The primary purpose of this position is to ensure optimal resource decisions are made and executed across civil engineer activities, and ensure data and information from all shops…
Added 12 mins ago
Sales Engineer
Caterpillar, Inc.
Griffin, GA · Alpharetta, GA
Caterpillar’s Electric Power Division has an open opportunity as a Sales Engineer. The Sales Engineer will support go-to-market initiatives, and sales execution as a subject matter expert…
Added 12 mins ago
Managing Consultant, Integrated Planning Job Details | Black & Veatch Family of Companies
Black & Veatch
Atlanta, GA
Lead the execution of resource planning for utilities and large electric users, guiding technical teams and energy market modeling (e.g., PLEXOS, EnCompass) to inform client strategy,…
Added 34 mins ago
Process Engineer II / 505997 / Starkville, MS
Spectraforce Technologies Inc.
Starkville, MS
Added 34 mins ago
Track Supervisor 106246
Canadian Pacific
Meridian, MS
Added 34 mins ago
Senior Associate, Okta Identity Governance Enginee
KPMG LLP
Jackson, MS
Added 34 mins ago
Manager, Identity Access Management
KPMG LLP
Jackson, MS
Added 34 mins ago
ENGINEER TEST 1 - ALIGNMENT SPECIALIST
HII
Pascagoula, MS
The Engineer Test (Alignment Specialist) supports alignment, measurement, and verification activities for radar and gun foundations within the Test & Trials organization. This role requires…
Added 34 mins ago
UO
CIRES/NOAA Global Monitoring Laboratory, Research Engineer in Support of Atmosph
University of Colorado Denver
Boulder, CO
- $60,724 to $90,535 USD / year
The Cooperative Institute for Research in Environmental Sciences (CIRES) is seeking a research engineer to support the NOAA Global Monitoring Laboratory's (GML) Technology Transitions,…
Added 34 mins ago
UO
Senior Systems Engineering / Deputy Project Systems Engineer
University of Colorado Denver
Boulder, CO
- $120,416 to $189,585 USD / year
As the Deputy Project Systems engineer, you will work with the Lead Project Systems Engineer to carve out a role in the technical leadership and support of LASP payloads as well as…
Added 34 mins ago
UO
Senior FPGA Development Engineer
University of Colorado Denver
Boulder, CO
- $34,986 USD / year
The Laboratory for Atmospheric and Space Physics (LASP) is seeking an FPGA Design Engineer IV to serve as a senior technical leader for flight digital logic used in spaceflight science…
Added 35 mins ago
Senior Integration Engineer - M&A
BKF
Remote, United States
The Senior M&A Technology Integration Engineer is the technical lead for integrating acquired companies into BKF’s technology environment. Working with the Lead, M&A Technology Integration,…
Added 35 mins ago
Senior Integration Engineer - M&A
BKF
Remote, United States
The Senior M&A Technology Integration Engineer is the technical lead for integrating acquired companies into BKF’s technology environment. Working with the Lead, M&A Technology Integration,…
Added 35 mins ago
Senior Integration Engineer - M&A
BKF
Remote, United States
The Senior M&A Technology Integration Engineer is the technical lead for integrating acquired companies into BKF’s technology environment. Working with the Lead, M&A Technology Integration,…
Added 35 mins ago
Senior Integration Engineer - M&A
BKF
Remote, United States
The Senior M&A Technology Integration Engineer is the technical lead for integrating acquired companies into BKF’s technology environment. Working with the Lead, M&A Technology Integration,…
Added 35 mins ago
Senior Integration Engineer - M&A
BKF
Remote, United States
The Senior M&A Technology Integration Engineer is the technical lead for integrating acquired companies into BKF’s technology environment. Working with the Lead, M&A Technology Integration,…
Added 35 mins ago
Senior Integration Engineer - M&A
BKF
Remote, United States
The Senior M&A Technology Integration Engineer is the technical lead for integrating acquired companies into BKF’s technology environment. Working with the Lead, M&A Technology Integration,…
Added 35 mins ago
Systems Engineer - Mergers & Acquisitions Integration
BKF
Remote, United States
The Systems Engineer – M&A Integration executes technical integration activities associated with mergers and acquisitions. The role supports the onboarding of acquired companies into BKF’s…
Added 35 mins ago
Systems Engineer - Mergers & Acquisitions Integration
BKF
Remote, United States
The Systems Engineer – M&A Integration executes technical integration activities associated with mergers and acquisitions. The role supports the onboarding of acquired companies into BKF’s…
Added 35 mins ago
Systems Engineer - Mergers & Acquisitions Integration
BKF
Remote, United States
The Systems Engineer – M&A Integration executes technical integration activities associated with mergers and acquisitions. The role supports the onboarding of acquired companies into BKF’s…
Added 35 mins ago
Systems Engineer - Mergers & Acquisitions Integration
BKF
Remote, United States
The Systems Engineer – M&A Integration executes technical integration activities associated with mergers and acquisitions. The role supports the onboarding of acquired companies into BKF’s…
Added 35 mins ago
Systems Engineer - Mergers & Acquisitions Integration
BKF
Remote, United States
The Systems Engineer – M&A Integration executes technical integration activities associated with mergers and acquisitions. The role supports the onboarding of acquired companies into BKF’s…
Added 35 mins ago
Systems Engineer - Mergers & Acquisitions Integration
BKF
Remote, United States
The Systems Engineer – M&A Integration executes technical integration activities associated with mergers and acquisitions. The role supports the onboarding of acquired companies into BKF’s…
Added 42 mins ago
Product Manager, Data Management
Amentum
Merrifield, VA
…coordinates with supporting groups such as test, integration and…
Added 1 hour ago
Senior Materials and Process Engineer
ColdQuanta
Louisville, CO
We are seeking a Senior Materials and Process Engineer to own materials and manufacturing process development for the Quantum Gravity Gradiometer (QGG) program. This hands-on role turns…

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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