Senior Officer Quality Control

Job Title:

Senior Officer – Quality Control (Electronics & Medical Devices)

Department:

Quality Assurance – Women’s Health & Fertility Solutions

Location:

Vapi, Gujarat

Reports To:

Manager / Senior Manager – Quality Assurance

Job Purpose:

To ensure the quality, safety, and compliance of incoming materials, in-process assemblies, and finished medical devices used in Women’s Health & Fertility solutions by performing inspections, testing, calibration, and documentation in accordance with approved specifications, quality systems, and regulatory requirements.

Key Responsibilities: –

1. Incoming Material Inspection

• Inspect PCBs, electronic modules, sensors, power supplies, heaters, fans, motors, and controllers as per approved BOMs, drawings, and specifications.

• Verify supplier documentation including CoC, test reports, and traceability records.

• Perform visual, dimensional, and functional checks of incoming materials.

• Identify non-conforming materials and initiate NCRs as per quality procedures.

2. Functional & System Testing

• Perform functional testing of temperature, CO₂, O₂, and humidity control systems.

• Verify system behaviour under normal and abnormal operating conditions.

• Validate alarms, safety interlocks, and fault-handling mechanisms.

• Ensure system performance meets defined acceptance criteria.

3. Calibration & Sensor Validation

• Calibrate environmental sensors (temperature, CO₂, O₂, RH) using approved methods and reference standards.

• Maintain calibration records, labels, and traceability logs.

• Identify out-of-tolerance conditions and support corrective actions.

• Support periodic re-calibration and verification activities.

4. In-Process & Final Quality Inspection

• Conduct in-process quality inspections during assembly and integration stages.

• Perform final inspection and release testing of finished devices.

• Verify HMI functionality, data logging, display accuracy, and system responses.

• Ensure products meet quality, safety, and regulatory requirements prior to release.

5. Failure Analysis & Corrective Actions

• Analyse test failures and deviations during incoming, in-process, or final inspections.

• Support root cause analysis (RCA) using structured problem-solving tools.

• Participate in corrective and preventive action (CAPA) implementation and verification.

• Provide feedback to engineering, manufacturing, and suppliers for quality improvement.

6. Documentation & Regulatory Compliance

• Maintain QC documentation in line with ISO 13485 and CDSCO requirements.

• Ensure accurate recording of inspection results, test data, calibration records, and batch history.

• Support traceability, change control, and document control activities.

• Participate in internal, customer, and regulatory audits.

7. ESD, Safety & Process Compliance

• Ensure compliance with ESD control procedures during handling and testing of electronic assemblies.

• Follow safety protocols during testing of electrical and thermal systems.

• Adhere to approved SOPs, work instructions, and quality plans.

• Support training and awareness on quality and safety practices.

8. Continuous Improvement & Audit Support

• Support quality improvement initiatives to reduce defects and rework.

• Participate in audit preparation, responses, and follow-up actions.

• Provide inputs for process optimization and inspection effectiveness.

• Support validation, production ramp-up, and field quality issues as required.

Qualifications and Experience:

• Diploma / B.E. / B.Tech in Electronics, Electrical, Instrumentation, or related field.

• 4–7 years of experience in quality inspection, testing, or calibration of electronic or medical devices.

• Experience in medical devices, diagnostics, or regulated manufacturing environments preferred.

• Hands-on experience with testing instruments and calibration equipment.

Skills and Competencies:

• Strong understanding of electronics, sensors, and control systems.

• Hands-on experience in functional testing and calibration of environmental systems.

• Good knowledge of ISO 13485 and CDSCO regulatory requirements.

• Familiarity with ESD, safety standards, and inspection best practices.

• Strong analytical and problem-solving skills.

• High attention to detail and documentation accuracy.

• Ability to work effectively in a regulated, cross-functional environment.

• Good communication and coordination skills.

Key Performance Indicators (KPIs):

• First time-right inspection and testing accuracy.

• Reduction in incoming and in-process non-conformances.

• Timely completion of inspections and calibration activities.

• Audit readiness and compliance with regulatory requirements.

• Effective support to RCA, CAPA, and continuous improvement initiatives.