Supplier Quality Engineer

Now Hiring:

Supplier Quality Engineer – Medical Devices

Location:
United States

Industry:
Medical Devices

Experience:
5+ Years

Role Overview

We are seeking an experienced
Supplier Quality Engineer (SQE)
to support
supplier quality management
for medical device products. This role ensures suppliers meet
FDA and ISO requirements
, drives supplier performance improvement, and supports new supplier qualification, audits, and ongoing compliance activities.

Key Responsibilities

• Manage
  supplier qualification, evaluation, and monitoring
  activities
• Conduct
  supplier audits
  (on-site and remote) per
  ISO 13485 and FDA 21 CFR 820
• Review and approve
  PPAP / First Article Inspection (FAI)
  documentation
• Support
  incoming inspection
  and supplier-related
  nonconformances
• Lead
  supplier CAPA
  , root cause analysis, and effectiveness checks
• Support
  change control
  related to supplier or material changes
• Collaborate with
  Purchasing, R&D, Manufacturing, and Quality
  teams
• Support
  risk management
  activities for suppliers (FMEA, risk assessments)
• Ensure supplier compliance during
  regulatory inspections

Required Qualifications

• Bachelor's degree in
  Engineering or related technical field
• 5+ years of experience
  as a
  Supplier Quality Engineer
  in the medical device industry
• Strong knowledge of
  ISO 13485
  ,
  FDA 21 CFR 820
  , and supplier quality systems
• Experience with
  supplier audits, CAPA, and change management
• Strong documentation and communication skills

Key Skills

Supplier Quality Management | Supplier Audits

ISO 13485 | FDA 21 CFR 820

CAPA | Root Cause Analysis

PPAP | FAI | Incoming Inspection

Risk Management | Supplier Qualification

Change Control | Regulatory Compliance

Interested candidates, please share your updated resume to