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Specialist- I, ICAP Q&R Process QA &QE

2.00 to 3.00 Years   Bangalore   03 Feb, 2021
Philips
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

null#LI-PHILINJob Title : Specialist- I, ICAP Q&R Process QA &QELocation : BangaloreYour challenge :Perform a wide variety of activities pertaining to compliance with applicable regulatory requirements, quality management system (QMS) maintenance, improvement and harmonization, and quality control and assurance.Responsibilities:

  • 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.
  • Produces and completes SW Quality Engineering documents under direct supervision.
  • Responsible for performing timely, detailed SW Quality engineering tasks like: assessing software designs and reviewing test and other performance data, analyses market feedback, completing or assisting with in root cause analysis and SW Quality problem solving.
  • May also provide other SW quality engineering support, including assisting organizational units in addressing SW Quality engineering deficiencies.
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, 21 CFR Parts 803,806, and 820, ISO 9001)
  • 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.
  • Knowledge of product creation and (software) development methods & tools
  • Experience in using problem solving tools
  • Knowledge of external regulations and standards relevant for our products
  • Ability to translate legal/Regulatory requirements in to procedures and instructions
  • Over all experience of 7 to 10 years with minimum 2 to 3 years in Medical Device domain
Why should you join Philips Working at Philips is more than a job. It s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.To find out more about what it s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there,you can also learn about our recruitment process, or find answers to some of the frequently asked questions.ContactIf you forgot your password, you can click theForgot Passwordbutton on the Sign In screen to reset it.If you have any other questions regarding the recruitment process please refer to ourFAQs.In case of technicaldifficulties with the website,please send an emailto careersite@philips.com .(Note: To ensure fairness and legal compliance in our recruitment processes,only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.),

Keyskills :
iso 14971medical devicesiso 13485root causequality management systemroot cause analysis21 cfrmusic makingquality controlquality management systems

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