Job Description

Job Title: Quality Engineer ( bio engineer or Mechanical)

Medical Devices Location:

[Insert Location]

Job Type:

Full-Time

Department:

Quality Assurance

Reports To:

Quality Manager / Director of Quality

Job Summary:

We are seeking a highly motivated and detail-oriented

Quality Engineer

with

medical device industry experience

to join our Quality Assurance team. The Quality Engineer will be responsible for ensuring compliance with regulatory requirements, supporting product development, maintaining quality systems, and driving continuous improvement initiatives in accordance with FDA, ISO 13485, and other applicable standards.

Key Responsibilities:

Ensure compliance with

FDA 21 CFR Part 820

,

ISO 13485

,

MDR

, and other applicable regulations and standards. Lead or support

CAPA (Corrective and Preventive Actions)

investigations, root cause analysis, and implementation of effective solutions. Participate in

risk management

activities (e.g., FMEA) during product development and post-market phases. Review and approve

validation/qualification protocols and reports

(IQ/OQ/PQ) for processes, equipment, and software. Support internal and external audits (FDA, Notified Body, ISO, etc.); assist with audit preparation and responses to findings. Collaborate with R&D, manufacturing, and regulatory affairs to ensure quality requirements are met throughout the product lifecycle. Monitor and analyze product and process trends using

statistical tools

(SPC, DOE, etc.) to drive continuous improvement. Review and improve

standard operating procedures (SOPs)

, work instructions, and quality documents. Manage

nonconformance investigations

, including root cause analysis, impact assessments, and corrective actions. Participate in supplier quality management, including audits, performance reviews, and incoming inspection plans.

Qualifications:

Bachelor's degree

in Engineering, Life Sciences, or related field (Mechanical, Biomedical, etc.)

0-2+ years of experience

in a Quality Engineering role within the

medical device industry

In-depth knowledge of

FDA QSR

,

ISO 13485

,

ISO 14971

, and preferably

EU MDR

Experience with

CAPA

,

risk management

,

validation

,

design control

, and

root cause analysis

Proficient in

quality tools and techniques

(e.g., 5 Whys, Fishbone Diagram, FMEA, SPC, Minitab) Strong communication skills with ability to work cross-functionally

CQE, CQA, or Six Sigma

certification is a plus
Job Type: Permanent

Pay: ₹18,000.00 - ₹25,000.00 per month

Benefits:

Health insurance Provident Fund
Work Location: In person