Job Summary :

This role to ensure that all sterile medical devices manufactured at the plant meet the highest standards of quality, safety, and compliance. He / She must have strong understanding of regulatory requirements (such as ISO 13485, Indian Medical Device Rule-2017 etc) with respect to inspection & testing, and hands-on experience with quality control processes in a cleanroom or GMP-compliant environment.

Key Responsibilities:

· Supervise the team perform in-process and final inspection of sterile medical devices and components.

· Conduct sampling, testing, and documentation of raw & packaging materials, finished goods, sales return product, Stability study etc.

· Involve customer complaint investigation process and prepare necessary investigation reports.

· Ensure compliance with applicable regulatory standards (ISO 13485,IMDR, MDR etc.).

· Maintain and calibrate QC instruments and equipment.

· Prepare and review QC documentation, including SOP's, inspection reports, COA, and deviation reports.

· Participate in internal audits and support external regulatory inspections.

· Identify and report non-conformities and assist in root cause analysis and CAPA implementation.

· Collaborate with production, R&D and QA teams to ensure product quality.

· Maintain cleanroom protocols and hygiene standards during inspections.

Qualifications & Skill

· Bachelor’s degree in Science, Engineering, Pharmacy, or a related field.

· 4-6 years of experience in quality control within the medical device industry.

· Familiarity with GMP, ISO 13485, and IMDR regulations.

· Proficient in using QC tools and instruments 

· Strong documentation and analytical skills.

· Good communication and teamwork abilities.

· Experience with statistical quality control (SQC) and SPC tools.