- Position/Designation : Quality Inspector
- Department : Quality
- Location : Bangalore
- Age : 20 years & above
- Academic Qualifications : Degree/Diploma in Mechanical Engineering is preferred
- Experience (Years) : 0 to 2 years preferred
- Industries in which candidate has worked : Process / quality inspections in medical device, pharma & healthcare industry in the manufacture of plastic based products, Injection Molding preferably.
- Communication and Presentation Skills : Good communication skills in English (spoken & written).

Position Scope &

- Purpose:

Maintains quality standards by sampling, inspecting & labeling (physical & mechanical checks & tests) of incoming materials & components as used in the manufacture of molded parts, sub-assemblies & finished medical devices as per control plans, SOPs &

- WIs. Assures accuracy & correctness of data & maintains inspection results in Medical Device Batch Records.

Contacts

This position interacts with all levels of employees & suppliers appropriately.

Equipment Used

Vernier Caliper, Micrometer, Height Gauge, Pin/Plug Gauges, Go/No-Go Gauges, etc..

Key Accountabilities/Essential Functions:

Incoimg Inspection

- Inspect incoming raw materials, components, and bought-out parts as per approved specifications , SOPs and inspection plans.
- Verify dimensions, visual characteristics, quantity, identification, and applicable CoC/CoA documents.
- Perform inspection as per approved sampling plans/AQL requirements.
- Identify, segregate, and report nonconforming materials.
- Maintain incoming inspection records and traceability.

Product/Process Inspection

- Perform Start-up, in-process/patrol and End-up inspections during manufacturing and assembly operations.
- Verify product dimensions, visual characteristics, and critical quality parameters.
- Ensure production is carried out as per approved drawings, SOPs, Work Instructions, and Quality Control Plans.
- Communicate quality deviations to Production and Quality personnel.
- Support containment and re-inspection activities.





WIP/Final Inspection

- Perform WIP and final inspection of molded components , semi finished and finished products products as per approved checklists.
- Verify appearance, labeling, packaging, and quantity as applicable.
- Complete final inspection records accurately and maintain product traceability.
- Support Quality personnel in product release activities.

Measurement &

- Testing:

- Operate and handle measuring and inspection equipment as mentioned above equipment used section.
- Verify calibration status before using measuring equipment.
- Handle measuring instruments properly and report any damage or abnormality.

Nonconformance Control

- Identify and quarantine nonconforming materials/products.
- Initiate NCR/NCMR documentation as applicable.
- Support defect investigation, containment action and re-inspection of rewoked products.
- Support and provide inspection data for root-cause analysis, CAPA, and continuous improvement activities.

Documentation &

- Records:

- Complete inspection reports, check sheets, test records, and other quality records accurately.
- Follow the GMP / GDP requirements
- Maintain proper identification and traceability of materials and products.
- Ensure inspection records are completed in accordance with approved plan and checklists.
- Maintain the inspection records, and relvent records to the Medical Device Batch Record (MDBR) for accuracy and completenes.

Technical/Functional Skill Sets

- Reading and understading the 2D drawings and instructions.
- Inspection of plastics injection molded & assembled medical devices.
- Basic problem-solving skills.
- Quality Management System (QMS) Requirements (QA / QC)-perferably ISO 13485.
- Valuable communication and teamwork.
- General proficiency in computer applications like MS Word, Excel, Powerpoint, Outlook, etc..

Personal Qualities/Characteristics required for the position:

- While performing the duties of this job, the employees in regularly required to stand; walk,& sit for extended periods of time. Should be willing to work in night shifts & weekends.

📌 Quality Inspector (Bengaluru)
🏢 SMC
📍 Bengaluru