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.

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Executive - Quality Control