Quality System Manager

440y Varian Medical Systems International (India) Private Limited; India; On-site; INR 2,500,000 - 3,500,000; Full time

Job summary

Siemens Healthineers is seeking a seasoned Quality System Manager to drive regulatory compliance and quality strategy for software-based medical device development. You will lead QA activities, manage CAPA, and coordinate global audits to ensure adherence to ISO 13485, IEC 62304, and FDA requirements.

The role focuses on establishing robust quality systems, mentoring a team of quality professionals, and partnering with cross-functional groups to advance product quality and patient safety across

Qualifications

• Bachelor’s or master’s degree in computer science, information technology, software engineering, or a related technical field.

Responsibilities

• Lead the establishment, implementation, and maintenance of quality system requirements for SaMD development in line with procedures and standards.
• Develop, mentor, and lead a team of quality professionals to support compliance and product quality.
• Drive CAPA and continuous improvement across functions to enhance quality performance.
• Partner across functions to identify quality risks, business opportunities and process improvements.
• Implement process improvements and leverage AI-enabled tools to improve productivity and compliance.
• Authorize and oversee software design projects per the QMS and conduct design reviews.
• Serve as primary contact for escalations related to software design and engineering quality.
• Use data analytics to track quality metrics, trends, and risk areas for action planning.
• Manage DHF and regulatory documentation for submissions and approvals.
• Lead Quality Review Board meetings with data-driven insights and corrective actions.
• Plan and coordinate internal and external audits with global teams and agencies.

Skills

Regulatory knowledge

Medical devices

ISO 13485

FDA Regulations

IEC 62304

MDSAP

QA leadership

AI tools

Education

Bachelor’s or Master’s degree in computer science or related field

Tools

CAPA system

Agile/Scrum

AI tools

Job description

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Establishes the defined Quality Management system tailored/aligned to the project-specific requirements to ensure process and product quality in service/solution project to achieve customer satisfaction and business success. Acts as a member of the project core team with special focus on failure prevention. Advocates to a higher quality aspiration. The Quality System Manager plays a critical role in advancing quality systems, regulatory compliance, and business performance for software-based medical device development. This position is responsible for driving quality strategy execution in alignment with site quality management and business leadership priorities, while ensuring compliance with applicable international regulations, standards, and global regulatory expectations.

Key responsibilities include:

• Lead the establishment, implementation, and maintenance of quality system requirements and business objectives for medical device software and Software as a Medical Device (SaMD) development projects in alignment with applicable procedures, regulations, and international standards.
• Develop, mentor, and lead a team of quality professionals to support compliance, business growth, product quality, and customer experience.
• Drive continuous improvement initiatives and organizational change efforts that enhance business agility, quality performance, and operational effectiveness, including through the CAPA system.
• Partner effectively across functions to identify and address quality risks, business opportunities, and process improvement priorities.
• Implement process and compliance improvements, leverage AI-enabled tools where appropriate to improve productivity and provide guidance or training on new and revised regulatory standards, quality procedures, and process changes.
• Authorize and oversee software design projects in accordance with the quality management system and applicable product standards, including leading design reviews at key development stages.
• Serve as a primary point of contact for escalations and cross‑functional issues related to software design and engineering projects, ensuring timely and effective resolution aligned with quality requirements and business values.
• Apply strong analytical skills to assess quality data, identify trends and compliance risks, and drive improvement actions through quality plans and CAPA activities.
• Manage Design History Files (DHF) and technical documentation to ensure ongoing compliance with applicable regulations, and coordinate regulatory submissions required for product or process approvals, certifications, or licenses.
• Lead Quality Review Board activities by presenting meaningful quality metrics and trends to support data‑driven decision‑making, corrective actions, and preventive actions.
• Plan and coordinate internal and external audit activities for the site and collaborate with global teams and external agencies as part of broader quality audit programs.

Qualifications and Experience:

• Bachelor’s or master’s degree in computer science, information technology, software engineering, or a related technical field is required.
• 8–10 years of experience in the healthcare IT or medical device industry, preferably in software medical device or SaMD environments across software development, quality assurance, verification and validation, and deployment.
• 3–4 years of people management experience, with demonstrated success in leading, coaching, and developing quality professionals.
• 2–3 years of experience as a quality systems auditor, including lead auditor certification from a recognized institution.
• Experience establishing and maintaining quality management systems in healthcare IT or SaMD environments is strongly preferred, particularly within radiology or radiation therapy domains.
• Professional certifications such as Certified Internal Auditor, Lead Auditor for ISO 13485, MDSAP, IEC 62304, Software Quality Assurance (SQA), FDA 21 CFR Part 820, or EU MDR are highly desirable.
• Hands‑on end‑to‑end software development lifecycle experience is preferred, including software design quality assurance, risk management, post‑market surveillance, supply chain quality, and regulatory submissions.
• Experience working in Agile or Scrum development environments with Artificial Intelligence (AI) tools is preferred.

Attributes and Skills:

• Strong working knowledge of applicable medical device regulations and standards, including FDA regulations, ISO 13485, ISO 14971, IEC 62304, MDSAP, and EU MDR.
• Solid understanding of the software development lifecycle, software quality assurance principles, and SaMD regulatory expectations.
• Experience leading or coordinating quality assurance and regulatory activities within cross‑functional and globally distributed teams.
• Ability to influence stakeholders across functions, communicate effectively, and build productive working relationships in an international environment.
• Familiarity with radiotherapy systems or related healthcare technologies is an advantage.
• Willingness to travel domestically and internationally, as required.

Who we are:

We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision‑making and treatment pathways.

As an equal opportunity employer, we welcome applications from individuals with disabilities.

How we work:

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. To find out more about Healthineers’ specific businesses, please visit our company page here.

As an equal opportunity employer, we welcome applications from individuals with disabilities.

Data Privacy:

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously.

Our culture:

We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world.

We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed.

We spark ideas that lead to positive impact and continued success.