
Quality Assurance Manager
3 days ago
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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