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Job Information

Philips Sr. Technical Specialist - Quality in Bangalore, India

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Responsibilities :

Perform a wide variety of activities pertaining to compliance with applicable regulatory requirements, Product risk management, quality management system (QMS) maintenance, improvement and harmonization, and quality control and assurance.

  • Accountable for oversight of quality and risk management throughout the product lifecycle

  • Verification of execution of processes and their deliverables in product creation and subcontracting projects and report the findings to upper management.

  • Review and Approval of designated project documentation in product creation projects.

  • Advice to product creation projects concerning the definition and implementation of quality assurance activities

  • Advise upper management with respect to release for delivery of products

  • Support and represent Q&R discipline in Design Reviews, Hazard Analysis brainstorms, Health Risk Assessments

  • Initiate, stimulate, and support the implementation of process improvements

  • Execution of audits in all business processes and report the findings to upper management

  • Support and advise the organization in corrective and preventive actions

  • Participate in the maintenance, improvement and deployment of the Quality Management System

  • Translates regulations and standards and bring them to consolidation in the organization and the Quality Management System

  • Represent the approbation officer in projects and support in the activities to acquire product licenses and approvals

  • Participation in and verification off changes to DMR and release orders where Q&R involvement is needed.

Qualifications and Know-How :

  • Bachelor or Master degree in relevant knowledge domain, e.g.: Computer Science, electronics, Electrical or information technology.

  • Knowledge of relevant external standards for Quality Management Systems for medical devices (e.g. ISO13485, ISO 14971, MDD, FDA-QSR)

  • Knowledge of (software) processes and procedures

  • Qualified Auditor of Quality Systems ( Preferable)

  • Good skills in reporting, both in writing and oral

  • Fluent speaker and writer in English

  • Project management knowledge and skills.

  • Sound knowledge of the basic functionality of our products

  • Knowledge of product creation and (software) development methods & tools

  • Experience in using problem solving tools

  • Experience in working with legal documents

  • Knowledge of external regulations and standards relevant for our products

  • Ability to translate legal requirements in to procedures and instructions

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