Quality Manager (ISO 9001, ISO 13485, EU MDR, FDA, Information Security-ISO 27001, GDPR)
Siemens
IT, Quality Assurance
Bengaluru, Karnataka, India
Posted on Apr 15, 2025
Job Description
Job ID
460988
Company
Siemens Healthineers India LLP
Organization
Siemens Healthineers
Job Family
Quality Management
Experience Level
Experienced Professional
Full Time / Part Time
Full-time
Contract Type
Permanent
Role: Quality Professional
Desired/Preferred Qualifications: BE / B. Tech/MCA
Experience: 7-12 years of experience in SW Quality Assurance.
- Job Description:
- Ensuring compliance (of products & services) with legal and normative requirements for organization (including tailoring of processes as appropriate) Quality Management System.
- Demonstrate ability to advanced technologies, processes, and practices in quality management. Serve as the leading point of authority and/or source of process knowledge for area of expertise.
- Support the Project Manager and Application Manager in activities related to the development and/or implementation of the software-specific quality activities in projects or changes (including project related Quality Reporting).
- Support the Quality team in implementation and compliance to ISO9001, ISO 13485 and 21 CFR Part 11 implementation for the assigned projects, applications and changes as defined in ITSM (IT process framework).
- Coach the project and application team members in Quality Management System and Processes application to ensure high customer satisfaction.
- Active participation in the complete lifecycle process of our Healthcare devices - starting with product pilot to end of Support including improving of product and process quality and effective solution for potential quality problems (e.g., Identify the project Risks, participation in project steering groups, Change Control Boards, document reviews, etc)
- Perform Release Reviews & Milestone Reviews as per project milestones.
- Monitoring and control of corrective actions in the R&D projects.
- Consulting & training of team members in implementing and realizing the defined processes.
- Conducting/participating in Process Audits, Internal Audits and External Audits, Supplier audits.
- Coordination and ensuring closure of audit findings within the projects.
- Provide input and drive continuous quality improvement initiatives in the organization.
· Collaborate well with the counterpart for BA/BL Quality and share the knowledge across the network, where applicable.
- Collaborate with all stakeholders to implement lean /agile initiatives across organization.
- Guide teams with Agile/Lean principles and practices (E.g. Reduce waste, VSM) to deliver value frequently and regularly to the customers.
Knowledge and Experience:
- Expertise in Quality Management System standards and regulations (e.g. ISO 9001, ISO 13485, EU MDR, FDA, Information Security-ISO 27001, GDPR etc.)
· Understanding of foundational PM principles including management of scope, schedule, budget, risk, resources, quality, communications, suppliers, stakeholders, and team operations.
- Possess Internal Auditor/Lead Auditor Certifications from notified bodies.
- Experience in facing external audits and conducting internal audits.
- Experience in implementing Agile/Lean Principles and Practices within projects.
- Excellent in critical thinking, interpersonal skills, and ability to work independently on problems.
- Strong written and oral communication skills
- Good moderation and presentation skills and ability to interact with various levels of management.