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Philips Software Technologist - C++ 
India, Karnataka, Bengaluru 
978392859

Today

Your responsibilities

  • Instruct, coach and facilitate project team’s w.r.t Quality Management System (Procedures/ Policies/ Guidelines/ tools/ training, etc.).
  • Instruct, coach and facilitate project teams on relevant product standards (IEC60335/IEC60601/21 CFR820/ISO13485, etc.)
  • Drives and supports quality & regulatory compliance to assure products & services comply with the Quality Management System / Business Management System requirements
  • Create quality function deliverables as per Innovation Site Eindhoven –Quality Management System in projects, in Life Cycle Management and in Post Market Surveillance.
  • Review Requirements Management process and outcome.
  • Reviews Product Verification and Validation.
  • Ensure Risk Management quality (quality of UFMEA, DFMEA, PFMEA/HB-SRA, etc.).
  • Ensure compliance to quality system requirements, regulations and standards in designated area of responsibility.
  • Ensures timely execution and required communications and escalation.

We are looking for

  • Bachelor degree with 5+ years of related experience or a Master degree with 3+ years of related experience.
  • Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
  • Preferably experience in a medical device industry.
  • Proven ability to successfully incorporate and manage stakeholder needs throughout a project
  • Communicate globally, across teams and programs, from senior executives to administrative support personnel. Experience leading remote teams.
  • Both detail oriented and able to see big picture