Siemens Careers

Lead Quality Engineer

Bengaluru, India
Research & Development

English (UK)

Job Description

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 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

Job ID: 95725

Organisation: Siemens Healthineers

Experience Level: Mid-level Professional

Job Type: Full-time

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