Quality Assurance Specialist
We are seeking a skilled Quality Assurance Specialist to support and strengthen our Quality Management System (QMS) in a highly regulated pharmaceutical/medical device environment.
Key Responsibilities
* Maintain and improve the QMS in compliance with ISO 13485 and GMP standards.
* Coordinate internal and external audits, ensuring seamless execution and effective follow-up.
* Track and report on CAPAs, deviations, non-conformances, and change controls, providing actionable insights for improvement.
* Manage controlled documents, including SOPs, policies, batch records, and technical documentation, to ensure accuracy and accessibility.
* Support risk assessments and change management processes, leveraging expertise to mitigate potential risks and drive business growth.
* Ensure audit-ready documentation for inspections and management reviews, fostering a culture of excellence and compliance.
The ideal candidate will possess a degree in Science, Engineering, or Quality Management, with 2+ years of experience in quality/document control within pharma or medical devices. Strong knowledge of GMP and ISO 13485 standards is essential, along with proficiency in electronic document management systems and MS Office.
Requirements
* Strong analytical and problem-solving skills, with excellent attention to detail and communication abilities.
* Internal Auditor certification (ISO 13485) is desirable but not mandatory.
This role offers an opportunity to work in a dynamic environment, driving process improvements and contributing to the success of our organization.
Benefits
* A competitive salary package.
* A comprehensive benefits program, including health insurance and retirement plans.
* Ongoing training and professional development opportunities.
What We Offer
* A collaborative and supportive work environment.
* A chance to make a meaningful impact on the quality of our products and services.
* Opportunities for career growth and advancement.