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HA
Software QA Manager
Health Advocate Solutions, Inc.
Remote, United States
- Up to $140,000 USD / year
Help People. Grow a Team. Build Better Software.
Added 1 min ago
G
Civil Engineer - Land Development/Design
GPAC
Aurora, CO
- $115,000 to $145,000 USD / year
A well-established, reputable, and growing engineering and land planning firm, is looking for a Civil Engineer. We work hard to ensure that our projects are planned, designed & managed to…
Added 1 min ago
Civil Structural Engineer
GPAC
Roswell, GA
We are seeking a Structural Design Engineer to join our growing team. This role offers the opportunity to participate in every phase of structural engineering projects, from preliminary…
Added 1 min ago
Mechanical Engineer, Equipment Technologies Delivery
Hatch
Pittsburgh, PA
Are you looking to take the next step in your career? Hatch is seeking a Mechanical Engineer for Equipment Technologies Delivery to join our team in the Pittsburgh, PA office.
Added 2 mins ago
Civil Structural Engineer
GPAC
Chicago, IL
We are seeking a Structural Design Engineer to join our growing team. This role offers the opportunity to participate in every phase of structural engineering projects, from preliminary…
Added 2 mins ago
Civil Structural Engineer
GPAC
Chicago, IL
We are seeking a Structural Design Engineer to join our growing team. This role offers the opportunity to participate in every phase of structural engineering projects, from preliminary…
Added 2 mins ago
Civil Structural Engineer
GPAC
Norcross, GA
We are seeking a Structural Design Engineer to join our growing team. This role offers the opportunity to participate in every phase of structural engineering projects, from preliminary…
Added 2 mins ago
Senior .Net AI Software Engineer
3Core Systems, Inc
Deerfield Beach, FL
Engineer with executive presence. This is a SOFTWARE ENGINEER JOB WITH
Added 2 mins ago
Civil Structural Engineer
GPAC
Chicago, IL
We are seeking a Structural Design Engineer to join our growing team. This role offers the opportunity to participate in every phase of structural engineering projects, from preliminary…
Added 2 mins ago
Civil Structural Engineer
GPAC
Chicago, IL
We are seeking a Structural Design Engineer to join our growing team. This role offers the opportunity to participate in every phase of structural engineering projects, from preliminary…
Added 2 mins ago
Civil Structural Engineer
GPAC
Roswell, GA
We are seeking a Structural Design Engineer to join our growing team. This role offers the opportunity to participate in every phase of structural engineering projects, from preliminary…
Added 2 mins ago
Civil Structural Engineer
GPAC
Chicago, IL
We are seeking a Structural Design Engineer to join our growing team. This role offers the opportunity to participate in every phase of structural engineering projects, from preliminary…
Added 2 mins ago
G
Civil Engineer - Land Development/Design
GPAC
Lakewood, CO
- $115,000 to $145,000 USD / year
A well-established, reputable, and growing engineering and land planning firm, is looking for a Civil Engineer. We work hard to ensure that our projects are planned, designed & managed to…
Added 2 mins ago
G
Civil Engineer - Land Development/Design
GPAC
Lakewood, CO
- $115,000 to $145,000 USD / year
A well-established, reputable, and growing engineering and land planning firm, is looking for a Civil Engineer. We work hard to ensure that our projects are planned, designed & managed to…
Added 2 mins ago
G
Civil Engineer - Land Development/Design
GPAC
Lakewood, CO
- $115,000 to $145,000 USD / year
A well-established, reputable, and growing engineering and land planning firm, is looking for a Civil Engineer. We work hard to ensure that our projects are planned, designed & managed to…
Added 2 mins ago
G
Civil Engineer - Land Development/Design
GPAC
Lakewood, CO
- $115,000 to $145,000 USD / year
A well-established, reputable, and growing engineering and land planning firm, is looking for a Civil Engineer. We work hard to ensure that our projects are planned, designed & managed to…
Added 3 mins ago
AS
Test Engineer II
Air Squared Manufacturing, LLC
Thornton, CO
- $82,000 to $98,000 USD / year
We are seeking a Test Engineer II to join our growing team. This role is focused on designing test stands and testing new scroll compressors and vacuum pump designs, including liquid-cooled…
Added 3 mins ago
Reliability Engineer
Louisville, CO · Salt Lake City, UT · Houston, TX
The Reliability Engineer supports a larger operations team and serves as a domain expert for technical and engineering matters related to the reliable and available operation of MV/HV…
Added 3 mins ago
G
Civil Engineer - Land Development/Design
GPAC
Greenville, SC
- $115,000 to $145,000 USD / year
A well-established, reputable, and growing engineering and land planning firm, is looking for a Civil Engineer. We work hard to ensure that our projects are planned, designed & managed to…
Added 4 mins ago
CI
Senior Systems Engineer
Cintal, Inc.
Chillicothe, IL
- $80,000 to $105,000 USD / year
This is not primarily a software developer position. Programming experience is valuable, especially for test automation, but the core focus of the role is Requirements Engineering,…
Added 4 mins ago
Sr. Silicon Design Engineer: Hardware-Software Co-Design
Advanced Mircro Devices, Inc.
Bellevue, WA
The AMD AI Group is looking for a Senior Silicon Design Engineer to co-design the hardware-software interface for AMD Instinct GPUs. You will work with hardware architects to model and…
Added 4 mins ago
G
Civil Engineer - Land Development/Design
GPAC
Englewood, CO
- $115,000 to $145,000 USD / year
A well-established, reputable, and growing engineering and land planning firm, is looking for a Civil Engineer. We work hard to ensure that our projects are planned, designed & managed to…
Added 4 mins ago
G
Civil Engineer - Land Development/Design
GPAC
Lakewood, CO
- $115,000 to $145,000 USD / year
A well-established, reputable, and growing engineering and land planning firm, is looking for a Civil Engineer. We work hard to ensure that our projects are planned, designed & managed to…
Added 4 mins ago
G
Civil Engineer - Land Development/Design
GPAC
Lakewood, CO
- $115,000 to $145,000 USD / year
A well-established, reputable, and growing engineering and land planning firm, is looking for a Civil Engineer. We work hard to ensure that our projects are planned, designed & managed to…
Added 5 mins ago
Senior Full Stack AI Engineer (US Citizen)
Remote, United States
Serve as a senior, hands-on full-stack AI engineer, leading the design, development, and delivery of large-scale mission-critical AI systems.

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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