Job Requirements: 

• At least 25 years of total experience in Medical Devices Manufacturing  

• At least 10 years of experience in Production function in a medical device/in vitro diagnostics manufacturing organization 

• At least 3 years of experience as General Manager/Plant Manager in manufacturing of disposable medical devices/in vitro diagnostics 

• Experience with ISO 13485 and CE audits 

• Strong understanding of requirements and compliance to ISO 13485 Standard as well as EU-MDR regulations   

• Demonstrated ability to deliver high-quality and consistent production of medical devices 

• Diligent and Result-Oriented 

• Experience in manufacturing of IV Catheters 

• Experience in manufacturing of Pre-Filled Syringes 

• Experience in Tool Room/Mould-making 

• Skilled in use of Solid Works software 

• Injection Moulding & Extrusion 

• Device Assembly 

• Blister Packaging & Cartoning 

• Ethylene Oxide Gas Sterilization 

• Plant Maintenance 

• Quality Control 

• Raw Material Store 

• Human Resources 

• Settled/Located in Chandigarh/ Baddi area 

• Good written and spoken English 

Job Responsibilities: 

• Ensure Compliance to EN ISO 13485, EU MDR regulations and 21 CFR 820 standards  

• Ensure consistent and high-quality production at > 90% of total installed capacity 

• Ensure compliance of production to Product Design documents in Technical File, viz. Bill of Materials, Product/Component Drawings and Artworks 

• Oversee and implement Capacity Expansion at Unit-2 including installation of Production Equipment/Assembly Lines, Product Validation and Manufacturing activities 

• Face all regulatory and customer audits  

• Ensure effective Preventive Maintenance of all installed equipment and minimizing break-downs/down-time in various production equipment 

• Maintain morale of employees with consistent/fair and constructive HR policies and interventions