Operation Manager for medical factory

Job Description

Oversee and optimize medical device manufacturing processes (ventilator circuits, nasal cannulas, oxygen masks).

Ensure compliance with ISO 13485, ISO 11135, and other relevant medical device standards.

Manage daily production activities to improve efficiency, reduce waste, and ensure product quality.

Support process validation, documentation, and continuous improvement initiatives.

Coordinate with QA/QC teams and support regulatory audits (SFDA / CE / ISO).

Desired Candidate Profile

Indian

Master of Technology/Engineering(Production/Industrial), Master of Science(Technology), MBA/PG Diploma in Business Mgmt

Male

Bachelor’s or Diploma in Engineering, Manufacturing, or a related technical field. 3–8 years of experience in medical device or plastic disposable manufacturing. Hands-on experience in cleanroom (ISO 7/8) environments is preferred. Familiar with EO sterilization, molding/extrusion, or assembly line operations. Knowledge of ISO 13485 / ISO 11135 standards (FDA experience is a plus, not required). Able to lead small teams, train operators, and implement process improvements.