Lead 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 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
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