Quality Assurance Manager

3 days ago

Siālkot, Punjab, Pakistan Technimen Agha (Pvt) Ltd. Full time 1,200,000 - 3,600,000 per year

Technimen Agha is a trusted manufacturer of high-quality surgical instruments, dedicated to innovation, safety, and precision. We operate in compliance with international standards and regulatory requirements to ensure our products consistently meet the needs of healthcare professionals and patients worldwide.

We are seeking a 
Quality Assurance / ISO Manager
 to lead our Quality Management System (QMS) and ensure compliance with 
ISO 13485
 and related standards. This role is critical in safeguarding product quality, regulatory adherence, and continuous improvement across our organization.

Key Responsibilities

  • Manage and maintain the company's 
    QMS in line with ISO 13485, ISO 14971, ISO 15883
    , and other applicable regulations.
  • Lead 
    internal and external audits
     (regulatory, notified body, supplier).
  • Oversee 
    process validations
     for special processes such as cleaning, passivation, electropolishing, and laser marking.
  • Develop and implement 
    risk management strategies
     in compliance with ISO 14971.
  • Ensure 
    document control
    , CAPA, nonconformance handling, and change management are executed effectively.
  • Collaborate with production, R&D, and regulatory teams to ensure seamless compliance.
  • Train and support staff on quality and compliance requirements.
  • Drive a culture of 
    continuous improvement
     across the organization.

Qualifications & Skills

  • Bachelor's degree in Engineering, Life Sciences, or a related field.
  • Minimum 3-4 years of experience in Quality Assurance within the 
    medical device or surgical instruments industry
    .
  • Strong knowledge of 
    ISO 13485, ISO 14971, and related regulatory frameworks
     (FDA 21 CFR Part 820, MDR preferred).
  • Experience in 
    auditing, process validation, and risk management
    .
  • Excellent problem-solving, organizational, and communication skills.
  • Leadership experience with the ability to influence cross-functional teams.

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