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Quality Engineer

Job Description

Quality Engineer 

     

Standards and Regulations 

   

  • Good knowledge of the relevant Standards/Regulations for medical device manufacturers (ISO 13485, ISO 14971, MDD, MDR, 510(k) etc.) 

  • Ensuring compliance of products as per MI PLM and SHPL QMS requirements 

  • Co-ordination with Quality Assurance Manager on various SHPL QMS related activities 

  • Conducting/participating in Internal Audits and External Audits,  

  • Coordination and ensuring closure of audit findings within the projects 

   

Process Management 

   

  • Supporting for maintaining and improving of product and process quality 

  • Lean/Agile Implementation 

  • Skills to Collaborate with all stakeholders to implement lean /agile initiatives across organization 

  • Guide teams with Agile/Lean principles and practices (E.g. Reduce waste, VSM) to deliver value frequently and regularly to the customers 

  • Quantitative Project Management using statistical methods  

   

Desired Qualification and Experience 

      

Qualification :  BE / B.Tech/ /MCA 

  

   

Experience: 5 to 8 years’ experience in SW Development / Testing / Quality Assurance. 

    

Knowledge and Experience: 

   

  • Knowledge of Quality and Process Management and related standards (e.g. ISO 13485,  ISO 14971, MDD, MDR, IEC 62304 etc) 

  • Possess Internal Auditor/Lead Auditor Certifications from notified bodies 

  • Experience in facing and conducting Audits required. 

  • Experience in healthcare domain is desired. 

  • Experience in implementing Agile/Lean Principles and Practices in projects 

  • Strong written and oral communication skills 

  • Excellent interpersonal skills and ability to work independently on problems. 

  • Have good moderation and presentation skills and ability to interact with various levels of management 

  • Ability to effectively communicate and interact with different stakeholders of the organization 

 

Business Title-Senior Engineer - Quality Management 

Designation- Quality Engineer 

 


Organization: Siemens Healthineers

Company: Siemens Healthcare Private Limited

Experience Level: Experienced Professional

Full / Part time: Full-time

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