Quality Engineer

BOMBAY ORTHO INDUSTRIES PRIVATE LIMITED- A wholly owned subsidiary of Alkem MedTech Pvt Ltd

4 - 9 years

6 - 8 Lacs

Rajkot

Posted:2 weeks ago| Platform:

Apply

Skills Required

FDA 21 Cfr Quality Assurance Capa Dhf RMF

Work Mode

Work from Office

Job Type

Full Time

Job Description

Purpose of the role:

The Design Quality Engineer will be responsible for ensuring the design, development, and manufacturing processes comply with regulatory requirements, industry standards, and company quality policies. This role will involve close collaboration with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Quality Assurance.

Roles & Responsibilities:

Ensure design control activities comply with applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485) and standards (e.g., ISO 14971, IEC 62366).
Participate in design reviews and provide quality engineering support throughout the product development lifecycle.
Establish and maintain Design History Files (DHF) and Risk Management Files (RMF).
Conduct design verification and validation activities, ensuring product safety and efficacy.
Develop and implement risk management activities including Failure Mode and Effects Analysis (FMEA).
Collaborate with cross-functional teams to ensure effective design transfer from R&D to manufacturing.
Support the creation and review of technical documentation, including design inputs/outputs, specifications, and reports.
Manage non-conformances, CAPAs, and change management activities related to design quality.
Provide guidance on regulatory requirements and standards related to orthopedic implant design.
Participate in internal and external audits, including regulatory inspections.

More Jobs at BOMBAY ORTHO INDUSTRIES PRIVATE LIMITED- A wholly owned subsidiary of Alkem MedTech Pvt Ltd

Quality Engineer

Rajkot

4.0 - 9.0 yrs

INR 6 - 8 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

Enhance Your Skills

Practice coding challenges to boost your skills

Start Practicing Now

BOMBAY ORTHO INDUSTRIES PRIVATE LIMITED- A wholly owned subsidiary of Alkem MedTech Pvt Ltd

Login to

Please Verify Your Phone or Email

Confirm Action

Search

Profile

Upskill and Grow with AI

Quality Engineer