Job Position: Plant Head for an Electrical Medical Device Manufacturing Unit.
Location: Greater Noida
Department: Manufacturing / Operations
Reports to: Director
Job Description
The Plant Head is responsible for the overall setting up and further management of the manufacturing facility, ensuring efficient production, regulatory compliance (EN ISO 13485, IEC 60601, IS/IEC 80601-02, IS 13450, US FDA, EU MDR), product quality, and operational excellence. The role includes supervision of production, quality, engineering, supply chain, and maintenance activities in accordance with applicable medical device regulations and standards.
Key Responsibilities
- Lead greenfield plant setup, project planning, timelines & risk management
- Oversee end to end manufacturing operations of electrical medical devices.
- Ensure production planning, target achievement & process optimization.
- Maintain compliance with ISO 13485, Indian MDR 2017, BIS, IEC 60601, IS/IEC 80601-02, IS 13450, IS 11378 & GMP
- Support regulatory audits and maintain TCF documentation
- Drive QMS, CAPA, non conformity management, product quality & coordinate with QA/QC teams
- Supervise engineering, maintenance & equipment calibration
- Manage supply chain, inventory control & vendor coordination
- Lead cross functional teams across production, engineering & operations.
- Implement lean manufacturing & continuous improvement initiatives along with providing training to employees
- Ensure proper documentation: BMR/DHR, equipment maintenance logs, calibration records & production planning reports
Qualifications & Skills
- Bachelor's or Master's degree in Electrical/Electronics/Instrumentation/ Biomedical Engineering
- 10-15 years manufacturing experience, minimum 5 years leadership role
- Strong knowledge of ISO 13485, IEC, EI, EMC standards & regulatory compliance
- Expertise in production planning, operations & team leadership
- Experience in plant setup of medical manufacturing unit
Interested candidates can send their resumes on: [Confidential Information]
