Quality Inspector

1. Position/Designation** ** : Quality Inspector

2. Department : Quality

3. Location : Bangalore

4. Age : 20 years & above

5. Academic Qualifications : Degree/Diploma in Mechanical Engineering is preferred

6. Experience (Years) : 0 to 2 years preferred

7. 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.

8. 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.

• Good 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.