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Quality Professional

4 months ago

bangalore, India Siemens Healthcare Private Limited Full time
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: 15 to 20 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 SAFe 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