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Sr. Technical Specialist - Quality

4.00 to 5.00 Years   Bangalore   08 Nov, 2020
Philips
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaGeneral / Other Software,Quality (QA-QC)
EmploymentTypeFull-time

Job Description

nullThe Quality Engineer is accountable for oversight of system and hardware quality and risk management throughout the product life cycle.The Quality Engineer provides independent oversight of the design input process, design V&V activities, design transfer and productrealization, and performance in the field to ensure that all design requirements are effectively met. The Quality Engineer also providesanalytics to the Business on the efficacy and efficiency of the design and product realization processesResponsibilities: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
,

Keyskills :
windowstroubleshootingenvironmentslacustomer relationsrisk managementmedical devicesproblem solvingquality systemshazard analysiscomputer sciencequality assurancemanagement systemquality management

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