Change Control Job Vacancies in Telangana

Job Title - Engineering Change Specialist (Medical Devices) Remote (India)India RemoteMust have minimum 6 hours overlap with US ESTExperience: 510 YearsJob DescriptionWe are looking for an experienced Change Specialist with strong medical deviceindustry experience.Responsibilities: Manage and process ECOs / Change Requests Coordinate approvals with Engineering, Quality, Manufacturing, and Supply Chain Support capital equipment change orders & POs Ensure version control, traceability, and audit readiness Support internal/external auditsRequirements: 510 years in Medical Devices Strong hands-on experience in ECO Change Management Knowledge of FDA QSR & ISO 13485 Experience with PLM/EDMS tools (Windchill / Agile / Arena or similar)

The Technical Specialist will be responsible for analyzing and improving business processes through process mapping, workflow analysis, and business process management techniques. They will be expected to have a strong understanding of Lean methodologies, Six Sigma, and change management principles to drive process improvements within the organization.The Technical Specialist will also be responsible for managing projects related to process optimization, data analysis, and statistical process control. They will be required to conduct root cause analysis, gap analysis, and requirements gathering to identify opportunities for process improvement.

Job Opportunity: Change Management Role (5+ Years Experience into functional support) Role: Change ManagementQualification: any graduate/PG (B.Tech will be not suitable)Experience: 5+ YearsLocation: Hyderabad/BangaloreCTC: Up to 10 LPA (Maximum 30% hike on last drawn CTC)Shift Timing: US Shift (4:30 PM - 1:30 AM) How to Apply:Send your updated CV to Mohd Khaja at khaja@liveconnections.in or call 8297221110. Mention Change Management in the subject line.

Ensure line clearance, reviewing of BMR & BPR. Handling of shop floor QMS Documents and compliances

1.BMR Preparation and BMR Reviewing.2.Change Control Reviewing and Closing.3.Protocol Preparation and Closing.4.Report Preparation and closing.5.Deviation Preparation.6.Qualification Preparation.7.Raw material indent in SAP.8.System work should be required.9.Consumption coefficient Preparation.

CAPA, Change control, Deviation, RCA. SOPs, STPs, MOA's & distribution to various departments. IQ, OQ, PQ, Production, Ensure line clearance, reviewing of BMR& BPR Handling of shop floor QMS Documents and compliances

1. Master STP and relevant work sheet and AR review/ revision.2. Analytical Method validation protocol, monitoring and report (9 No's - 2020)3. Investigations of incidents (139 No's - 2020)4. QC SOP revision (Review, Print, signature followup)5. Review of daly, monthly, quarterly and annual calibrations and schedules.6. Organized data backup as per the schedule7. Stablity study initiation as part of CCF/ Add on batch. accordingly protocols to be review and approval8. Review of IM & FP AWS recordsQMS:12. Change control handling (66 No's)13. Deviation Handling14. OOS handling15. Weekly meeting preparation16. MRM preparation17. Audit support.18. CAPA followup19. CAPA effectiveness20. Internal audits followup and closure