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Added 29 mins ago
IPS Analysis Chief (Associate Project Manager 2)
City of New York
Queens, NY
The Supervisor will provide direction and supervision to a team responsible for quality control and codification of operational activities recorded and maintained in the agency database of…
Added 30 mins ago
Certified Welder
Metromont LLC
Greenville, SC
…side-by-side with our customers from the earliest stages of project design through turnover of the completed structure. In addition to the production of precast concrete, Metromont provides…
Added 44 mins ago
MRI Technologist $20K Sign-On Incentive
Dana-Farber Cancer Institute
CHESTNUT HILL, MA
Under the direction of the MRI Manager/Supervisor, the MRI technologist performs all technical procedures within their respective modality obtaining high quality patient scans; is involved…
Added 44 mins ago
G
Commercial HVAC Project Manager
GPAC
San Diego, CA
- $75,000 to $120,000 USD / year
Engage all team members in quality issues to ensure that the quality control function is effectively performed
Added 44 mins ago
Quality Control Inspector III
Vitesse Systems
Clinton, MA
SUMMARY: The Quality Control Inspector III is an advanced level mechanical inspector role. The primary function of the role is to inspect components and assemblies for dimensional,…
Added 44 mins ago
Quality Control Inspector II
Vitesse Systems
Clinton, MA
SUMMARY: The Quality Control Inspector II is an intermediate level mechanical inspector role. The primary function of the role is to inspect components and assemblies for dimensional,…
Added 45 mins ago
G
Commercial HVAC Project Manager
GPAC
Denver, CO
- $75,000 to $120,000 USD / year
Engage all team members in quality issues to ensure that the quality control function is effectively performed
Added 1 hour ago
EC
Associate Manufacturing Engineer
Eaton Corporation
Jonesville, SC
- $59,000 to $86,000 USD / year
Creates, trains, and guides the optimal design and layout of cells and manufacturing flow lines considering safety/guarding, productivity, ergonomics, first pass yield, process and test…
Added 1 hour ago
Construction Quality Manager - Infrastructure
Burns & McDonnell
Kansas City, MO
The Construction Quality Manager is responsible for providing leadership, direction, and oversight of the Construction Global Practice (GP) Quality Management System (QMS) for Design-Build…
Added 1 hour ago
Security Solutions Architect II
Allied Universal
Wyoming, MI
…advanced technology - video surveillance, electronic access control, alarm monitoring and augmented solutions with physical security to help people feel safe. Whether you’re an installation…
Added 1 hour ago
Senior Insurance Product Development Manager - Multiline -Remote US
AF Group
Kalamazoo, MI
…lines, including business cases, opportunity analysis, product design, coverage language and implementation through the Product Development Life Cycle. * Collaborates with operating units…
Added 1 hour ago
MBSE Systems Tools Developer – Advanced Vehicle Development
General Motors
Warren, MI
Define integration requirements for data ownership, traceability, configuration control, automation, data quality, error handling, and supportability.
Added 1 hour ago
Senior Insurance Product Development Manager - Multiline -Remote US
AF Group
Lansing, MI
…lines, including business cases, opportunity analysis, product design, coverage language and implementation through the Product Development Life Cycle. * Collaborates with operating units…
Added 1 hour ago
G
Fire Sprinkler Design Manager
GPAC
Odenton, MD
- $120,000 to $150,000 USD / year
…to grow their already established team with a Fire Sprinkler Design Manger. This company prides themselves on their reputation and their commitment to delivering the highest quality fire…
Added 1 hour ago
G
Architecture Project Manager
GPAC
Grand Rapids, MI
- $90,000 to $110,000 USD / year
…career? An established, multidisciplinary architecture and design firm is seeking an Architecture Project Manager to join its team in the Grand Rapids, Michigan…
Added 1 hour ago
G
Architecture Project Manager
GPAC
Sterling Heights, MI
- $90,000 to $110,000 USD / year
…career? An established, multidisciplinary architecture and design firm is seeking an Architecture Project Manager to join its team in the Grand Rapids, Michigan…
Added 1 hour ago
G
Architecture Project Manager
GPAC
Ann Arbor, MI
- $90,000 to $110,000 USD / year
…career? An established, multidisciplinary architecture and design firm is seeking an Architecture Project Manager to join its team in the Grand Rapids, Michigan…
Added 1 hour ago
G
Architecture Project Manager
GPAC
Lansing, MI
- $90,000 to $110,000 USD / year
…career? An established, multidisciplinary architecture and design firm is seeking an Architecture Project Manager to join its team in the Grand Rapids, Michigan…
Added 1 hour ago
G
Architecture Project Manager
GPAC
Dearborn, MI
- $90,000 to $110,000 USD / year
…career? An established, multidisciplinary architecture and design firm is seeking an Architecture Project Manager to join its team in the Grand Rapids, Michigan…
Added 1 hour ago
G
Architecture Project Manager
GPAC
Livonia, MI
- $90,000 to $110,000 USD / year
…career? An established, multidisciplinary architecture and design firm is seeking an Architecture Project Manager to join its team in the Grand Rapids, Michigan…
Added 1 hour ago
Electrical Engineer II
Honeywell Technologies
Arvada, CO
Strong knowledge of electrical design principles, industry standards, and process control system best practices
Added 1 hour ago
G
Architecture Project Manager
GPAC
Westland, MI
- $90,000 to $110,000 USD / year
…career? An established, multidisciplinary architecture and design firm is seeking an Architecture Project Manager to join its team in the Grand Rapids, Michigan…
Added 1 hour ago
G
Architecture Project Manager
GPAC
Troy, MI
- $90,000 to $110,000 USD / year
…career? An established, multidisciplinary architecture and design firm is seeking an Architecture Project Manager to join its team in the Grand Rapids, Michigan…
Added 1 hour ago
CS
Bison Collaring Project Manager
Colorado State University
Fort Collins, CO
- $25 to $35 USD / hour
Experience designing data-collection protocols, aligning diverse data streams, and performing data quality control.
Added 1 hour ago
CI
Millwork Programming and Machining Lead
Concepts In Millwork
Colorado Springs, CO
- $26 to $32 USD / hour
…machining, ensuring our custom millwork moves seamlessly from design to fabrication. This role is an opportunity to combine technical expertise, problem-solving, and leadership to bring…

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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