Quality Assurance Engineer (Medical Device)

Overview

On Site
USD 90,000.00 - 105,000.00 per year
Full Time

Skills

Mergers and Acquisitions
Quality Assurance
Regulatory Compliance
Manufacturing Engineering
Documentation
Process Improvement
Product Development
Management
Medical Devices
Manufacturing
Corrective And Preventive Action
ISO 13485
Privacy
Marketing

Job Details

Location: Framingham, MA
Salary: $90,000.00 USD Annually - $105,000.00 USD Annually
Description:
Our client is currently seeking a Quality Assurance Engineer (Medical Device). This is a permanent, direct hire, on site role.

Key Responsibilities:

  • Investigate material nonconformance issues and resolve supplier concerns.
  • Maintain calibration system and ensure compliance with 21 CFR 820 & ISO 13485.
  • Support manufacturing engineering with documentation and process improvements.
  • Assist in product development and design transfer into manufacturing.
  • Perform incoming inspections and manage non-conforming reports.
  • Lead CAPA investigations and implement corrective actions.

Qualifications:
  • 3-5 years of experience in medical device manufacturing.
  • Strong CAPA and validation expertise.
  • Knowledge of 21 CFR 820 and ISO 13485


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Contact:

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