Senior global leadership role in Regulatory Affairs responsible for defining and executing the worldwide regulatory strategy for QIAGEN's IVD (In Vitro Diagnostics) and Life Sciences portfolio. Oversees all regulatory activities across the product lifecycle, including pre-market submissions, post-market surveillance, compliance, regulatory intelligence, and global team leadership.
Compensation
The estimated base salary range for this position is $250,000 - $300,000.
Responsibilities
Develop and execute the Global Regulatory Affairs strategy for the IVD and life sciences portfolios.
Ensure regulatory work supports company strategy, governance, and ongoing compliance.
Provide expert leadership on FDA, EU, and other major submission processes and requirements .
Partner with business leaders to assess impact, influence decisions, and support adoption of new or changing regulations.
Lead the regulatory assessment of product risk and safety issues.
Lead the software quality function while ensuring product software, firmware, and digital health platform services are designed, developed, verified and released in compliance with applicable quality systems.
Compensation
$150,000 - $175,000 plus discretionary annual bonus
Responsibilities
Recruit, mentor, coach and develop software quality engineers
Lead the software and firmware quality function for product software and cloud infrastructure including the digital health platform
Ensure the completeness and sufficiency of design requirements, architecture specifications, detailed design specifications, code review evidence, verification and validation evidence, risk management files, and traceability
Chair or oversee software change control boards and defect management processes
Build alignment with partner organizations including R&D, Regulatory, Operations, Security, Marketing, and Clinical
Requirements
BS in Computer Engineering
BS in Computer Science
BS in Electrical Engineering
related field
Nice to have: MS or higher in engineering or a software-related discipline
Support the implementation, maintenance, and continuous improvement of Quality Management System processes in alignment with global quality strategies, business requirements, and applicable regulatory standards.
Support CAPA and nonconformance management, including initiation, investigation, root cause analysis, action planning, implementation, effectiveness verification, and timely closure.
Partner with cross-functional teams to investigate quality issues, identify systemic risks, and implement sustainable corrective and preventive actions.
Participate in internal and external audit readiness activities, including audit preparation, evidence collection, response development, remediation activities, and closure of audit findings.
Support compliance with applicable quality and regulatory requirements, including ISO 13485:2016, FDA Quality Management System Regulation (QMSR), and other applicable standards and regulations.
Requirements
Bachelor's degree in Engineering, Quality Management, Life Sciences, or a related technical discipline
Lead end-to-end planning and execution of medical-device market expansion projects, from project initiation and market-specific gap assessment through registration, 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 elevate constraints with mitigation options.
Facilitate cross-functional working meetings and governance reviews; communicate status, decisions, actions
The Staff Quality Engineer serves as the Site Quality Lead and a member of the Site Leadership Team, providing strategic quality leadership across the product lifecycle. This role enables compliant innovation, drives continuous improvement, and ensures an effective Quality Management System supporting the site's responsibilities as an FDA-registered Specification Developer.
Compensation
The salary range estimated for this position based in Connecticut is $103,100.00–$150,000.00.
Responsibilities
Own the effectiveness of the site's Quality Management System, establishing priorities, balancing strategic initiatives with operational support, and ensuring compliance with applicable regulatory and corporate quality requirements.
Serve as the site's Management Representative, leading Management Review activities and communicating the health, performance, and effectiveness of the Quality Management System through meaningful quality metrics.
Provide strategic Quality leadership across the product lifecycle, from product development through commercialization and post-launch support.
Leverage quality system, product performance, customer feedback, complaint trends, and post-market data to identify emerging risks, drive systemic improvements, and influence product and process decisions across the product lifecycle.
Partner with Global Design Quality, Manufacturing, Supplier Quality, Regulatory Affairs, and cross-functional teams to ensure the site fulfills its responsibilities as an FDA-registered Specification Developer.
The primary responsibility of this position is to be the Quality Leader and Management Representative for the Colorado Springs site and is accountable for the effectiveness, compliance, and continual improvement of the Quality Management System.
Compensation
The expected salary range for this position is $125,000 – $150,000 annually.
Responsibilities
Follow Employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies practices, policies and Standard Operating Procedures to ensure that customer requirements and industry standards and regulations are met.
Demonstrates knowledge and acts in accordance with NMT’s Employee Guidelines and applicable quality standards as outlined in NMT’s Quality Manual.
Abides by all safety and security rules set forth by the company and regulatory agencies.
Responsible for maintenance and ongoing improvement of the Quality Management System.
Responsible for the establishment and tracking of Quality KPIs.
Lead the Supplier Quality Management organization across the Americas, providing strategic and operational leadership to ensure quality, reliability, and compliance of externally supplied components, materials, products, and services.
Compensation
The base pay range for this position is: $192,600 -264,825
Responsibilities
Lead, coach, and develop the Americas Supplier Quality Management organization
Provide strategic and operational leadership across the supplier quality lifecycle
Execute the global Supplier Quality Management strategy across the Americas
Establish and maintain effective Supplier Quality Management governance across the Americas
Ensure regional Supplier Quality activities and supplier controls comply with applicable Quality Management System and regulatory requirements (FDA QMSR, ISO 13485:2016, ISO 14971:2019, EU MDR)
Requirements
Bachelor's degree in Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, Materials Engineering, or another relevant field
Nice to have: Lean
Nice to have: Six Sigma
Nice to have: ASQ Certified Quality Engineer (CQE)
Nice to have: Certified Manager of Quality/Operational Excellence (CMQ/OE)
The QMS Engineer supports the establishment and continuous improvement of a compliant Quality Management System, developing and revising QMS process documents, managing document control, ensuring regulatory compliance, and reporting performance metrics.
Compensation
The base salary range for this role is €[Min]–€[Max]. This role is eligible for [bonus/incentive]
Responsibilities
Develop and revise QMS process documents such as SOPs and quality manuals
Manage document control and electronic document management systems
Ensure compliance with QMS standards and regulations
Collect, compile, and report QMS performance metrics
Participate in internal and external audits and root cause analysis
The QMS Specialist is responsible for supporting the establishment of a compliant and effective Quality Management System (QMS), including document development, root cause analysis, and reporting QMS performance metrics.
Compensation
The base salary range for this role is €[Min]–€[Max].
Responsibilities
Develop and revise QMS process documents such as SOPs and quality manuals
Collaborate with cross-functional teams to resolve quality issues through root cause analysis and corrective actions
Collect and report data on QMS performance metrics
Track non conformance reports
Participate in the planning and organization of internal audits
Senior Quality ManagerNissha · Colorado Springs, US
QMS EngineerPhilips · Bangalore, India