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Quality Engineer

Podrobnosti o osobě
490921
Zveřejněno od
13-Led-2026
Obor
Quality Management
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 - Karnataka - India
Mandatory Expectations

In this position, you are responsible for following the Document control process
  1. Activities related to SAP processing, role mapping, formatting, reference checks etc…
  2. Monthly review of SOPs to ensure compliance and updates
  3. Providing part numbers, SOP numbers, or validation numbers upon request
  4. Communicating changes related to Quality Records (QR) and General Documents (GD)
  5. Managing periodic reviews and status updates for Environmental Health and Safety (EHS) documents and meeting minutes
Additional Expectations

In this position, you are also responsible for
  1. Review the R-Reviews ( Phase exit milestones )
  2. Establish and monitor appropriate Project quality plans, targets / Objectives and methods based on laid down  standards, advise the project leader on project specific adaptations
  3. Quality Management and process controlling (key activities include monitoring and checking to make sure that the agreed key processes have been complied with)
  4. Tracking, analyzing, and performing Root Cause analysis 
    
Competencies
  • Practical knowledge of Good Documentation Practices (GDP) and SAP for upload, download and document control work.
  • Knowledge of the relevant Standards/Regulations for medical device manufacturers (ISO 13485, ISO 14971, MDD, MDR, 510(k) etc.)
  • Knowledge on Software Development Life Cycle and Process Lifecycle Management.
  • Ensuring compliance of products as per MI PLM and SHPL QMS requirements
  • Co-ordination with Quality Manager on various SHPL QMS related activities
  • Conducting/participating in Internal Audits and External Audits, 
  • Coordination and ensuring closure of audit findings within the projects.
 
Process Management 
  • Supporting for maintaining and improving of product and process quality
  • Skills to Collaborate with all stakeholders to implement lean /agile initiatives across organization
  • Quantitative Project Management using statistical methods 
  
Desired Qualification and Experience     
Qualification :  BE / B.Tech/ MCA
  
Experience: 4 to 6 years’ experience in Quality Assurance & Document control.