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2 weeks ago
Company Overview:
GPC Medical Ltd. is a renowned manufacturer and supplier of high-quality medical products, specializing in orthopedic implants and instruments.
We boast nearly a century of experience and adherence to ISO and WHO-GMP standards, offering a diverse range of products including CE-marked and US FDA 510(k) approved supplies.
Job Summary:
The ideal candidate will be responsible for preparing, reviewing, and implementing all quality management system (QMS) procedures to ensure compliance with regulatory requirements.
This role involves preparing technical files, conducting audits, managing risk assessments, and supporting the preparation of registration dossiers.
Key Responsibilities:
- QMS Procedures: Develop, review, and implement QMS procedures to meet regulatory standards and internal quality requirements.
- Technical File Preparation: Create and maintain accurate, complete, and compliant technical files for products.
- Audits: Conduct supplier audits and internal audits to ensure vendors and processes adhere to established quality standards.
- Risk Management & Documentation: Prepare and review essential risk management documents, including PMCF reports, CERs, product descriptions, and other related documentation.
- Document Control: Maintain and review the master list of documents, records, obsolete lists, CAPAs, and change control documentation to ensure accuracy and consistency.
- Regulatory Support: Assist in preparing and compiling dossiers for regulatory registration purposes, ensuring all necessary documentation is included and compliant with regulatory bodies.
Benefits:
This role offers a unique opportunity to work with a leading medical device company, contributing to the development and implementation of quality management systems that ensure compliance with regulatory requirements.