QMS Engineer Medihaven Co.

Employer Active

Posted 1 hrs ago

Experience

2 - 8 Years

Monthly Salary

SAR 2,500 - 5,000 ($676 - $1,351)

Job Location

Hafr Al Batin - Saudi Arabia

Education

Master of Technology/Engineering(Any, Production/Industrial)

Nationality

Indian, Pakistani

Gender

Male

Vacancy

1 Vacancy

Job Description

Roles & Responsibilities

Develop, implement, and maintain the Quality Management System (QMS) according to ISO 13485 and SFDA requirements. Prepare and control SOPs, forms, and quality documentation for all departments. Conduct internal audits and coordinate external audits (ISO / SFDA). Ensure compliance with ISO 11135 (EO sterilization) documentation and validation requirements. Work closely with Production, QC, and R&D to ensure process quality and continual improvement. Manage CAPA (Corrective and Preventive Actions), Change Control, and Non-Conformance reports. Maintain training records, calibration logs, and document revision control. Support management reviews and quality objectives tracking.

Desired Candidate Profile

Bachelor’s degree in Engineering, Biomedical, or Quality Management (or equivalent). 3–7 years of experience in medical device or plastic consumable manufacturing. Strong understanding of ISO 13485:2016 and awareness of ISO 11135 / CE / SFDA guidelines. Experience in cleanroom environments (ISO 7/8) preferred. Skilled in documentation, internal audit, CAPA, and process validation. Good communication skills in English (written and spoken). Ready to relocate to Saudi Arabia (visa and accommodation provided).

Employment Type

    Full Time

Company Industry

  • Medical
  • Healthcare
  • Diagnostics
  • Medical Devices

Department / Functional Area

  • Quality
  • Testing
  • QA
  • QC
  • Inspector

Keywords

  • Root Cause Analysis
  • Quality Auditing
  • QMS Specialist
  • Compliance Engineer
  • QMS Analyst
  • Continuous Improvement
  • Process Improvement
  • Quality Assurance Engineer

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Medihaven Co.

MEDIHAVEN, a Saudi medical device manufacturing company. We are now hiring experienced staff from India — preferably from medical device factories that produce ventilator circuits, nasal cannulas, and oxygen masks.