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Design Quality Assurance - Medical

Date Posted: Jun 29, 2026
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Job Detail

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    Location Pune, Maharashtra, India
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    Job Type: Full Time/Permanent
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    Shift:
  • analytics
    Career Level:
  • group
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    Experience:
  • male
    Gender: No Preference
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    Apply Before: Nov 14, 2026
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Job Description

BE/B.Tech Mechanical Only

Experience in medical device only

Responsibilities

Be a part of core project team and support the quality engineering across the entire development cycle

  • Lead product risk management, usability, reliability and design validation efforts for new product development and design change projects.
  • Lead the development and implementation of design verification and validation plans with project design lead.
  • Lead the development of Critical to Quality (CTQs), design input and output documents.
  • Lead the fixture qualification and test method validation.
  • Participate and implement tools like Design of Experiments (DOE’s), FMEA sessions, Risk Management and ensure compliance to CTQ’s and safety requirements.
  • Manage electronic document control and version control on all project related documents.
  • Ensure adherence to the quality systems and design assurance SOPs.
  • Lead usability, reliability, testing, verification and validation testing – internal and local vendors.
  • Provide statistical testing and reliability plans.
  • Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution.
  • Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable).
  • Co-Lead CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies).
  • Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed quality.

Technical requirements

QMS

Knowledge of Regulatory standards

CFR820 , ISO 13485 & 14971, 60601

Hands on experience on Risk Management.

Good understanding of Post Market Survey and complaint handling.

Design plan

Medical Process

DQC

Deviation and CAPA preferred.

Preferred skills

  • Foundational › Development process generic › Medical Device development process › Medical Device
  • Technology › Quality models/improvement frameworks › ISO 13485

About the role

  • Role: Engineering Lead
  • Experience: 6 - 10 years
  • Education: Bachelor of Engineering, Bachelor Of Technology

Source: Infosys careers — Read the original posting and apply

This role is listed by the employer on its own careers site. Kaam Ki Khoj does not process applications for it.

Company Overview

Infosys
Infosys · Bengaluru, Karnataka, India
1,811 open roles

Infosys is an employer in the IT/Computers - Software, Software Services sector with operations in India. This is a directory listing maintained by Kaam Ki Khoj so that candidates can find the organisation; it is not an official company page and Kaam... Read More

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