FDA Quality Management System Regulation (QMSR) jobs

Senior Design Quality Engineer

Boston Scientific · Posted Nov 9, 2026

Open

Yokneam, Israel
Full-time · Senior
4–6 years

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Senior Design Quality Engineer

Boston Scientific · Posted Nov 9, 2026

Open

Yokneam, Israel
Full-time · Senior
4–6 years

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Project Manager

Talent Software Services, Inc. · Posted Nov 6, 2026

Open

Raritan, New Jersey, United States
On-site
Full-time · Senior
6–8 years

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Lead medical-device market expansion projects, including product entry, registration, and launch readiness coordination.

Responsibilities

Lead end-to-end planning and execution of medical-device market expansion projects, from project initiation and market-specific gap assessment through registration and launch readiness.
Develop and maintain an integrated project plan covering regulatory strategy and submissions, technical documentation, clinical evidence, labeling and localization, manufacturing and supply readiness, and commercial launch dependencies.
Coordinate market-specific documentation gap assessments with Regulatory Affairs, Quality, R&D, Clinical Affairs, and Medical Affairs.
Manage schedules, resources, budget forecasts, and critical-path dependencies; maintain risks, assumptions, issues, and dependencies logs and escalate constraints with mitigation options.
Facilitate cross-functional working meetings and governance reviews; communicate status, decisions, and actions.

Requirements

Nice to have: orthopedic implants
Nice to have: surgical instruments
Nice to have: regional regulatory submissions
Nice to have: notified-body review coordination
Nice to have: UDI

Skills

medical-device market expansion projects management

Mgr, Quality Systems Operations

Siemens Healthineers · Posted Nov 4, 2026

Open

Full-time · Manager
$134K–$184K per year
5+ years

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The Quality Systems Operations Manager leads the effective operation, governance, and continuous improvement of Quality Management System (QMS) processes, with a primary focus on CAPA and nonconformance management, audit and compliance, quality performance management, risk-based quality practices, and continuous improvement.

Compensation

The base pay range for this position is: $133,740 - $183,887

Responsibilities

Lead, coach, and develop the Quality Systems team at the site, establishing clear objectives, priorities, responsibilities, and performance expectations while ensuring appropriate capabilities and resources are in place.
Lead the governance, maintenance, and continuous improvement of assigned Quality Management System processes, establishing clear process ownership, accountability, performance expectations, and escalation mechanisms.
Provide operational leadership and oversight for CAPA and nonconformance management, ensuring effective investigation, root cause analysis, corrective and preventive action, effectiveness verification, timely closure, and escalation of significant or systemic issues.
Lead internal and external audit readiness and regulatory inspection support, ensuring effective preparation, organizational alignment, response development, remediation, and timely closure of findings.
Ensure assigned QMS processes comply with applicable requirements, including ISO 13485:2016, ISO 14971:2019 Risk Management for Medical Devices, FDA Quality Management System Regulation (QMSR), and other applicable standards and regulations.

FDA Quality Management System Regulation (QMSR) jobs

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