Přeskočit na obsah Přeskočit na zápatí

Quality Professional – QMS Systems & Training Management

Podrobnosti o osobě
506632
Zveřejněno od
27-Kvě-2026
Obor
Engineering
Společnost
Siemens Healthcare Private Limited
Úroveň zkušeností
S dlouholetou praxí v oboru
Název pozice
Plný úvazek
Režim práce
Pouze na pracovišti
Druh smlouvy
Trvalý
Lokalita
  • Bengalúru - Karnátaka - Indie
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.