Quality Engineer - Medical Devices

Infosys; Pune District; On-site; INR 1,867,413 - 3,267,973; Full time

Job summary

A leading tech company in India is seeking candidates for a role focused on quality engineering within their engineering services line. Candidates should hold a Bachelor of Engineering or Technology and possess knowledge of regulatory standards such as ISO 13485. Responsibilities include leading usability and risk management efforts, supporting compliance with quality systems, and managing project-related documents to ensure product excellence. This is a vital position in the product development lifecycle.

Qualifications

• Bachelor of Engineering or Bachelor Of Technology required.
• Hands-on experience with Risk Management is preferred.
• Knowledge of post-market survey processes and complaint handling.

Responsibilities

• Be part of the core project team and support quality engineering.
• Lead product risk management and usability initiatives.
• Manage electronic document control for project documents.

Skills

QMS

Regulatory standards knowledge (CFR820, ISO 13485 & 14971, 60601)

Risk Management experience

Complaint handling knowledge

Education

Bachelor of Engineering

Bachelor Of Technology

Tools

Design of Experiments (DOE)

FMEA

Job description

Educational Requirements

Bachelor of Engineering, Bachelor Of Technology

Service Line

Engineering Services

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 and Professional 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