Quality and Regulatory Manager

Philips Healthcare, India

March 2016 to Actually working here

? Implementation of ISO 9001:2008 and ISO 13485 certification and surveillance for India site.
? CAPA management, Track-wise, QMS, ISO 13485 and ISO 9001 requirements, implementation.
? Management review in line with ISO9001 certification requirement
? Performing cross country (distant commercial organization for Philips) internal audit for ISO effectiveness
? Ensure training for all stake holders (Sales Team, Supply chain, Customer Support) of Ultrasound at regular intervals
? Addressing sales support for Ultrasound buyers
? Post Marketing Surveillance Manager for communication of surveillance results
? Establishing business management system as a management representative for Document control, Change control and functioning on BMS tools.
? Delivering training to employees through TEDs tool & maintain compliance rate for India site.
? Handling Srilanka regulatory, execution of medical equipment & devices registration
? Handling PC & PNDT certification and regulatory compliance for Ultrasound sales (Pre and post)

Quality Head

Paras Hospital, India

December 2013 to March 2016

? Formulating SOP?s, manuals for different departments as per JCI/ISO protocol.
? Ensuring regular update of licenses/registration/certifications as per JCI/ISO standard.
? Designing audit criteria?s for ensuring strict control mechanisms for smooth functioning of the hospital.
? Training new and existing staff about Quality process, it?s importance and adherence to JCI/ISO guidelines.
? Designing critical reports and dashboards for senior management.
? Implementing ?Surgical Safety? guidelines of World Health Organization (W.H.O).
? Implementing Clinical Excellence scorecard to assess clinical quality.
? Implementation of Non Clinical Excellence score card to maintain service quality in the hospital.
? Implementing Six Sigma (DMAIC, FMEA) methodology in all the departments

Quality Head

Panacea New Rise

October 2012 to August 2013

? Formulating SOP?s, manuals for different departments.
? Designing audit criteria?s for ensuring strict control mechanisms for smooth functioning of the hospital.
? Training the new and existing staff about Quality process, their importance and how to adhere to NABH guidelines.
? Formulating Quality indicators to measure and monitor the performance of various departments.

Quality Head

FORTIS HEALTHCARE LIMITED

September 2010 to October 2012

? Managing different departments in the hospital as per the JCI/ISO `protocol.
? Ensuring regular update of licenses/registration/certifications as per JCI/ISO standard.
? Implementing Clinical Excellence scorecard to assess clinical quality.
? Ensuring each department is JCI/ISO Compliant, FOS Compliant and comply with other audits too.
? Standardizing process & implementation of continuous quality improvement across the organization.
? Ensure implementation of all safety checklist and completion of facility round, code ?Mock Drill? etc.
? Developing Quality Culture in the hospital with the help of audit and training.

Assistant Manager

Artemis Hospital

September 2009 to September 2010

? Leading the team for JCI/ISO accreditation along with my peer for JCI/ISO accreditation.
? Performing trend analysis to analyze the performance of different departments and analyze the reason for (say) a dip in the performance and suggest improvement methods after discussing with the HOD?s.
? Performing daily, weekly and monthly audit reports of different departments to track the suggested changes? implementation.
? Initiating and designing the process of increasing the Patient Satisfaction Index by analyzing different departments.

Quality Assurance Officer

FORTIS HEALTHCARE LIMITED

December 2006 to December 2008

? To prepare Daily Business Report (DBR) having important parameters like revenue, collection and volume of each and every department like OPD, IPD, Radiology etc.
? To prepare Inpatient Summary in the specific IP formats in order to help the Finance Department.
? Development of a Medical MIS reporting system.
? To calculate & document the average consumption of consumables in package cases.
? To organize the training programs, symposium in collaboration with external agencies and companies.

Bachelors in Biology

Currently studying

Masters In Hospital Administration

Currently studying

Career Goals

Industries of interest

Areas of interest

Availability to travel and work outside the city

No

Interests and hobbies