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Quality Professional – QMS Systems & Training Management - job post

Siemens Healthineers
(part of Siemens)
3.8 out of 5 stars
Bengaluru, Karnataka
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Job details

Job type

  • Permanent
  • Full-time

Location

Bengaluru, Karnataka

Full job description

Position: Quality Professional – QMS Systems & Training Management
Responsibilities
Training Management
  • Manage and administer global training records, ensuring compliance with quality and regulatory requirements.
  • Act as backup for the Training Coordinator and support continuity of training operations.
  • Support preparation, coordination, and roll-out of self-study, virtual, and classroom trainings.
  • Extract, analyze, and provide training data for generic reports, role reviews, training plan clarifications, management reporting, and audit preparation.
  • Monitor training completion status and ensure timely follow-up on overdue and upcoming trainings
  • Maintain accurate and up-to-date training records in Learn4U (LMS tool).
  • Develop and implement AI-based tools and automation for training reminders and notifications (e.g., automated emails, Microsoft Teams notifications for upcoming/overdue trainings).
eQMS (ETQ) System Administration
  • Administer the ETQ eQMS, including user account creation, role/module access updates, and account deactivation.
  • Support training requests, upload training records, and ensure accurate filing within ETQ.
  • Manage the ETQ system mailbox and provide timely responses to user queries.
  • Provide general system support to employees and act as liaison with IT and ETQ support teams.
QMS Process Gap Assessments
  • Perform Quality Regulation (QR) gap analysis based on SHS requirements and assess impact to the Business Line QMS.
  • Conduct guidance and directive gap assessments and support impact evaluation and implementation within the QMS.
CAPA Management
  • Support CAPA management by connecting document revisions to CAPA activities.
  • Track CAPA timelines and status and provide resources and visibility to management.
  • Prepare and distribute weekly CAPA status communications.
Nonconformance (NC) / Planned Deviation Management
  • Perform periodic reviews of NCs and planned deviations to ensure compliance with QMS processes.
  • Proactively follow up with NC/Deviation owners to ensure timely completion of required deliverables.
Recall Management
  • Support recall activities by preparing status reports and extracting relevant information from relevant databases.
  • Develop AI-based tools to support data extraction and preparation of monthly recall reports.
Document Control Management
  • Support and manage document translation verification activities, including incorporation of approved translations into controlled documents.
  • Utilize AI-assisted tools to support translation verification where applicable.
  • Support document development, updates, and project documentation (e.g., new or updated documents related to SAP implementations).
  • Manage periodic document reviews once review cadence is established.
Internal and External Audit Management
  • Track internal and external audit findings and response due dates.
  • Coordinate follow-ups with audit response owners and send timely reminders.
  • Support site preparation for external audits, including document compilation, SME lists, and readiness activities.
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Required Knowledge / Skills, Education, and Experience
  • Bachelor’s degree in Engineering, Life Sciences, Quality, or a related field.
  • 3–7 years of experience in Quality Engineering, QMS support, or Quality Operations within the medical device or regulated industry.
  • Strong hands-on experience with training management systems (e.g., Learn4U or equivalent LMS) and eQMS tools such as ETQ.
  • Solid understanding of QMS processes including Training Management, CAPA, Nonconformance, Deviations, Document Control, Internal Audits, and Recall processes.
  • Experience supporting audits and inspections (internal and external).
  • Ability to extract, analyze, and present data for management reporting and audit readiness.
  • Exposure to automation, AI, or digital tools for quality process optimization is highly preferred.
  • Strong analytical, organizational, and problem-solving skills.
  • Excellent written and verbal communication skills with high attention to detail.
  • Ability to work effectively in a cross-functional and global team environment.
  • Fluent in English (written and spoken).
  • Flexibility to collaborate across global time zones, including limited overlap with US working hours, may be required. Occasional travel may be needed based on project requirements.
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