Qc Manager

Vasmed Technologies Ltd.; United Arab Emirates; On-site; AED 72,000; Full time

Job summary

An established industry player seeks a dedicated QC Manager to oversee quality control for innovative medical devices. This role requires a strong background in HPLC operation, method development, and regulatory compliance. You will lead a team in ensuring that drug-eluting stents and balloons meet stringent quality standards. If you are passionate about maintaining high-quality medical products and have a proven track record in quality inspection, this is the perfect opportunity to make a significant impact in the healthcare sector. Join a forward-thinking company where your expertise will help shape the future of medical technology.

Qualifications

• 5-7 years of hands-on experience in HPLC operation and GC Analysis.
• 2 years in a managerial position overseeing quality control.

Responsibilities

• Manage QC team and ensure quality of medical devices.
• Conduct inspections and manage documentation as per ICH requirements.

Skills

HPLC Operation

Method Development

Validation

Documentation Preparation

Regulatory Compliance

Education

B. Pharm

M. Pharm

M.Sc.

Biomedical Engineering

Tools

GC Analysis

Karl Fischer

Job description

Role & responsibilities

Job Description:

The QC Manager will be responsible for managing QC team and ensuring the quality medical devices drug eluting stents and balloons. The role includes proficient knowledge of HPLC Operation, method development, validation, documentation preparation, and compliance with regulatory and customer specifications.

Key Responsibilities:

Manage in-process and final inspection.

Manage and perform lot release testing using different equipment.

Conduct visual inspection under magnification (where required) for surface finish and critical features.

Manage documents including validation as per ICH requirement.

Prepare Inspection Reports, Final QC Reports, and In-Process QC Check Sheets.

Maintain and manage DHR (Device History Record) and DHR review documentation for medical devices.

Approve preparing COC (Certificate of Conformance), Test Certificates,

Ensure traceability and compliance with ISO 13485, GMP, and FDA standards where applicable

Preferred candidate profile

Education:

• B. Pharm, M. Pharm, M.Sc., Biomedical Engineering, or equivalent.

Experience:

5-7 years of hands-on experience in HPLC operation, GC Analysis, Karl Fischer and of that 2 years shall be as managerial position.

Experience in medical device quality inspection cardiology products (DES, Balloon catheters etc) is highly preferred.

Familiar with ISO 13485 / GMP standards for medical devices.

Strong documentation and reporting skills

Perks and benefits

• AED 72000 per annum + Accommodation