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General information

Location:
Bangalore - Karnataka, India - EOIZ Industrial Area
Job Family:
Engineering
Worker Type Reference:
Regular - Permanent
Pay Rate Type:
Salary
Career Level:
T4(A)
Job ID:
R-41359-2025

Description & Requirements

KEY RESPONSIBILITIES

  • Support the QARA leadership in building AI solutioning in QARA practice for healthcare & Life Sciences
  • Support the Sales & Presales in proposals and Technical discussions
  • Lead the QARA teams in delivery of the QARA projects ensuring Quality & Delivery on time every time
  • Collaborate with the AI team & other CFT in solution development in QARA Practice
  • Act as an SME in QARA project delivery
  • Upsell our QARA practice solutioning across the customer base
  • Support in the regulatory Strategy development for QARA Practice service wins across global customer base
  • Act as a catalyst in developing the QARA practice deliverables - AI Solutioning support, Sales Collateral development, Training,
  • Ensure the QARA practice teams knowledge management is at P95 for successful project delivery

Shall possess expertise in the below skills for solutioning / implementation

  • Communication Skills - Shall be able to communicate effectively in written and Oral methods
  • Global Medical Device Regulatory Affairs (India / Japan /  Australia /  Brazil / United States of America (US FDA) / Europe (EU MDR), MDSAP, Regulatory Reporting
  • Quality Management Systems (ISO 9001 /  ISO 13485 /  AS 9100), Risk Management (ISO 14971)
  • Standard’s exposure & experience – ISO 60601-x, ISO 10993-x, ISO 62366, 62304, 15223.
  • System Gap Assessments & Remediation, Systems Transition Planning, Testing
  • Mentoring & Coaching, Resource Management, Skill development, Training & Counselling
  • Compliance Auditing Learning & Development Continual Improvement, Policy & Program Designing
  • Clinical Evaluations Reporting, Medical Affairs
  • Post Market Surveillance, Complaints Handling & Processing, Complaints Management
  • Manufacturing Process Engineering, Engineering Change Management
  • Green & Brown Field setup Facilities Qualification, Manufacturing Management
  • Process Analysis, Process Verification and Validation, Utilities & Equipment Installation & Qualification
  • GDP, GMP. FMEA, KAIZEN, CAPA, QUALITY TOOLs

Shall possess professional Hands-on experience in

  • Attrition Control, Brand Building, Conflict management Customer relationship sustenance Global & Cross Functional Team Management
  • Liaison with Government bodies, Training & Skill development
  • Industry 4.0, LEAN Methodology, Smart Manufacturing,
  • Time and Motion Study, GREEN LEAN & SIX SIGMA
  • Operational Risk Management and Mitigation
  • Certification and Product Approvals
  • EHS (ISO 14001, BS 18001, ISO 45001)
  • Hands on experience in Operations of any Class 1, 2, 3 medical devices
  • Project or Program Management


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HARMAN is proud to be an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.