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    Quality Professional - Bengaluru, India - Siemens Healthcare Private Limited

    Siemens Healthcare Private Limited
    Siemens Healthcare Private Limited Bengaluru, India

    1 week ago

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    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 requirementsCo-ordination with Quality Manager on various SHPL QMS related activitiesConducting/participating in Internal Audits and External Audits,Coordination and ensuring closure of audit findings within the projectsProcess Management

    Supporting for maintaining and improving of product and process qualityLean/Agile ImplementationSkills to Collaborate with all stakeholders to implement lean /agile initiatives across organizationGuide teams with Agile/Lean principles and practices (E.g. Reduce waste, VSM) to deliver value frequently and regularly to the customersQuantitative Project Management using statistical methodsDesired 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 bodiesExperience in facing and conducting Audits required.
    Experience in healthcare domain is desired.

    Experience in implementing SAFe Principles and Practices in projectsStrong written and oral communication skillsExcellent interpersonal skills and ability to work independently on problems.

    Have good moderation and presentation skills and ability to interact with various levels of managementAbility to effectively communicate and interact with different stakeholders of the organization
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