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Quality Professional – QMS Systems & Training Management

Siemens Healthineers -
Bengaluru, Karnataka

Apply Now

Job details

Permanent | Full-time

Qualifications

SAP
Engineering
English
Quality management
Analysis skills
Bachelor's degree
AI
Communication skills

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.

________________________________________

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.

Apply Now

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