Kavita Sharma

• Accomplished multiple tasks within established timeframes.
• Monitored and analyzed business performance to identify areas of improvement and make necessary adjustments.
• Communicated clearly with employees, suppliers and stakeholders to keep everyone on same page and working toward established business goals.
• As a project lead, managed project performance to implement UDI barcode & manufacturing and registration of Custom Procedure Pack (CPP).
• Maintain the ISO 9001 certification for O&M Halyard Australia as this certification is required for business contracts and tenders.
• Continue to improve and optimize quality management system to ensure it meets both ISO 9001 and corporate quality system (ISO 13485: 2016) requirements.
• In conjunction with Process owners, develop and implement support process and procedures for all relevant areas of the O&M Halyard Australia organization.
• Assist initiators through document change process to ensure their processes and procedures are always kept up to date to reflect current practices.
• Maintain document change review and approval in the eQMS.
• Change Management
• Perform Quality Management System (QMS) audit and report results to Management.
• Be the O&M Halyard Australia “go to person” for Quality Non-Conformance (QNC), Corrective and Preventive Action (CAPA) and Change Control. Follow up on QNCs, CAPAs and Change Controls to ensure they are closed out on a timely basis.
• Coach team members and provide training on quality process, tools and systems
• Assist to handle O&M Halyard Australia Management Review.
• Ensure O&M Halyard Australia is always audit ready for Corporate and/or external Notified Body audits.
• Customer complaint coordinator
• Work with the Supply Chain Management team to ensure the ANZ Distribution Centers are complying to O&M Halyard quality system requirements.
• Support the O&M Halyard Australia Marketing team on new products and/or product improvements.
• Report QMR, Quality objectives, KPI
• Post market activities
• Collaborated with teachers, parents and administrators to facilitate positive outcomes for students.

• Prioritized project-related tasks to efficiently complete essential tasks.
• Prepared and submitted regulatory file applications and supporting documentation.
• Received, researched and resolved consumer inquiries.
• Responsible for re-registration project of the Spine fixation system.
• Registered Class 1, IIa and IIb medical devices including DoC preparations as per the Australian regulations.
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• Conducted QARA management responsibilities.
• championed and led the team through the certification of the organisation to ISO9001: 2015,
• Registered Class 1IVD, 2IVD, 3IVD medical devices with the TGA
• Post market vigilance
• Obtained import permits for biologics
• Provided quality and regulatory sound knowledge to management team,
• Reviewed labelling changes,
• Risk based approach
• Established a robust QMS.
• Experience in using SAP, trackwise and intranet - Livelink workflow.
• Quarterly QMR
• Leadership

• Kept up-to-date with changes in regulatory legislation and guidelines and obtained marketing permissions.
• Supplier audit
• Achieved milestone of 100% registration as a rebranding project.
• Registered several portfolios namely Respiratory & inhalation, medical supplies, wound care, Neonatal, dialysis catheters, surgical mesh, Class 1, IIa, IIb and Class III medical devices with TGA and Medsafe.
• Established good working relationship with key stakeholders.
• Post-market vigilance, product recall and complaint handling.

• Prepared and submitted regulatory file applications and supporting documentation.
• Prioritized project-related tasks to efficiently complete essential tasks.
• Conducted internal and external audit ISO9001

Key achievements in this role were:

• Planning and executing site quality matrix,
• QMS implementation for ANZ region within 4 weeks,
• Coordinated more than 20 product correction recalls.
• Registered In-vitro device applications with TGA and Medsafe.
• Registered Imaging & diagnostics systems, Ultrasound, Anesthesia delivery, diagnostic ECG, Maternal & infant Care, Patient monitoring, Ventilators, Healthcare IT, Refurbished equipment , parts and accessories.