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Quality Engineer - Engineering Change Management

Vacature ID
502770
Geplaatst sinds
17-apr-2026
Vakgebied
Quality Management
Bedrijf
Siemens Healthcare Private Limited
Ervaringsniveau
Experienced Professional
Type functie
Fulltime
Werkwijze
Alleen op kantoor/werkplaats
Type contract
Vast contract
Locatie(s)
  • Bangalore - Karnataka - India
Project Quality Engineer– Engineering Change Management

Role Overview
The Quality Engineer will be responsible for the end-to-end quality review and approval of Engineering Change Orders (ECOs) within the Product Lifecycle Management (PLM) system. This role ensures that changes to system components, electromechanical assemblies, and manufacturing processes are controlled, properly documented, and compliant with the Quality Management System (QMS).

Key Responsibilities
  • ECO Quality Review: Perform detailed reviews of Engineering Change Orders (ECOs), Engineering Change Requests and Deviations.
  • Review Impact Assessment: Ensure the impact of proposed changes on product safety, performance, manufacturing process/services are appropriately identified, verified and documented.
  • Documentation Compliance: Ensure all technical documentation, including Bill of Materials (BOM), CAD drawings, specifications, and Verification/Validation (V&V) reports, meet internal and external standards.
  • Cross-Functional Collaboration: Partner with R&D, Manufacturing Engineering, and Service to ensure that change rationale is clear and that risk management files are updated as necessary.
  • Process Improvement: Identify bottlenecks in the change control process and lead initiatives to streamline the ECO lifecycle without compromising quality.
Additional Responsibilities
  • Quality record review support: Provide support for review and approval of quality records (e.g., test records, verification evidence, and related attachments) to ensure completeness, accuracy, and traceability.
  • Quick update releases / mini projects: Serve as Quality Engineer (QE) support for quick update release projects or mini projects, providing rapid quality review, risk/impact assessment input, and timely approvals aligned with QMS requirements.
Required Qualifications
  • Education: Bachelor’s degree in mechanical engineering, Electrical Engineering, Biomedical Engineering, or a related technical field.
  • Experience: 5-8 years of experience in Quality Engineering, specifically within HW/Electromechanical system development or manufacturing.
  • Domain Expertise: Prior experience in a highly regulated industry (Medical Devices preferred).
  • Standards Knowledge: Familiarity with ISO 13485, ISO 14971, and FDA 21 CFR 820.70/820.30.
Technical Skills & Competencies
  • PLM Proficiency: Hands-on experience with PLM projects.
  • Analytical Mindset: Perform Root Cause Analysis (RCA) and assess the impacts of a component change on a complex system.
  • Attention to Detail: Analyze documentation errors, version control issues, and missing traceability.