Quality Engineer - Medical Devices

Infosys

5 years

0 Lacs

gurugram haryana india

Posted:23 hours ago| Platform:

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Skills Required

compliance drive risk scheduling assessment erp support sampling inspection audit data sigma certification measurement reliability management onboarding procurement engineering

Work Mode

On-site

Job Type

Full Time

Job Description

About the Role

Quality Engineer

Key Responsibilities

Plan and conduct
supplier quality system assessments
, including preparation, scheduling, and follow-up actions
Assess supplier capabilities through
site visits
,
technical discussions
, and
quality audits
Prepare detailed
assessment reports
and communicate quality issues to suppliers, driving corrective actions
Collaborate with
corporate and regional quality teams
on policy and guideline development
Track and trend
supplier performance
, implement remedial actions, and maintain ERP vendor profiles
Support suppliers in
statistical sampling plans
,
inspection methodology
, and
quality procedures
Ensure compliance with
ISO 13485
,
21 CFR Part 820
, and other regulatory standards
Handle
SCARs
,
CAPA
,
NCEP
, and audit outcomes
Lead activities related to
product recalls
,
risk management
, and
process validation
Perform
data collection
,
statistical analysis
, and implement Six Sigma methodologies for supplier improvements

Required Skills & Qualifications

5+ years of experience
in
medical device manufacturing
and supplier quality
Lead auditor certification or experience with
ISO 13485
audits
Strong understanding of
medical device regulatory requirements
for Class II & III devices
Hands-on experience in
risk management
,
CAPA
, and
post-market surveillance
Skilled in
Six Sigma tools
,
SPC
,
DOE
,
Measurement System Analysis
, and reliability techniques
Proficient in
vendor management systems
,
supplier onboarding assessments
, and
procurement processes

Location

Experience

Qualification

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