Engineer Maintenance @ BBraun Medical india

Job Title: Engineer Maintenance & Instrumentation

Job Family: Maintenance

Reporting to: Manager – Maintenance

Location: Dabilpur, Hyderabad.

1.0. Key Responsibilities

• Purpose & Responsibility of this position is to involve in establish ,implement and maintain an effective Quality Management System.                                               
• Involve in systems which will yield First time Right  Products  (Zero Defects)
• Responsibility of this position is to Promote awareness on regulatory and customer requirements.
• Responsible for regulatory affairs related activities with respect to State and Central Drug control authority                                       
• Ensure continuous compliance to local ,Divisional, national and International requirements with respects to Regulatory affairs, IMS, GMP, ISO 13485, MDD 93/42/EEC, MDR 2017/745.
• Build, sustain & strengthen a quality system in the plant and support production in reducing internal and external risks.                                        
• Understanding and learning various guidelines issued by the authority from time to time.
• Prepare necessary technical dossier for product registrations at various countries.

2.0. KRAs & Specific Roles

• Ensure timely delivery on ISO requirements in terms of Certifications, documentation,  periodic up gradations & All Audits.
• Investigating & Resolving Customer complaints/issues and ensure Corrective and Preventive Action ( CAPA).                                          
• Ensure compliance to GMP, local drug regulations and corporate requirements. 
• Make optimal utilization of resources within the given environment and work            
• Responsible for Risk management, change control, recall, sales return activities and review concern documents & reports.
• Responsible to maintain Product technical file for various requirement.
• Responsible for final release of the product to sales.  
• Maintain documents in B. Braun documentation and collaboration system.
• Design new label and implement label printing system.
• Liaising with regulatory authorities for all regulatory matters.
• Monitor all regulatory standard changes and implement system where necessary.
• Maintain technical file as per the requirement of EU MDR 2017/745, MDD/93/42/EEC, Medical Device Rule 2017

3.0. Key Competencies:

• The position should be well verse in QMS requirement according to ISO 13485.
• Excellent written and Verbal communication skills with the ability to listen, articulate and advocate.
• The position should be able to co-ordinate all regulatory and vigilance requirements and set the desired quality culture in the plant.
• Technical system skills (e.g. MS office applications, databases, efficient online research)                                

4.0. Educational Qualification and Experience

Education        :  B.Tech Mechanical, Electrical & instrumentation