Arabian Medical Products Manufacturing Co.
To Supervise all QA and QC activities and testing according to the international standard and to establish, document, implement and maintain the requirements of Quality Management System, according to CE, ISO 9001:2000, ISO 13485:2016 with certified on it, MDD 93/42/EE requirements. responsible for ensuring that the quality management system (QMS) is fully implemented in an organized and efficient manner.
PRINCIPAL DUTIES & RESPONSIBILITIES:
* Audit implementation of QMS and follow corrective measures and Manage individual audits and closed file reviews from beginning to end including audit, project planning, performance, reporting, Managing, organizing, and lead the Quality Assurance process.
* Monitors the inspection and testing performance according to quality plan and handle non-conformity products as well the coordination of document control and inspection records.
* Specifies the requirements of the validation for new and revised process.
Analyzes the specification and Prepares customized products specifications with tests and releases products.
* Coordinates QMS requirements and conducts trainings for all employees.
Monitors and assesses incoming materials and verifies the finished products with the specifications.
* Manages Lab activities for analyzing RM, finished goods, and components as well as microbiological testing.
* Reviews and approves customized products specifications.
* Coordinates customers’ complaints and activities including documentation,
* corrective actions, and verifications of the effectiveness of actions taken.
Evaluate and approve new suppliers.
* Promote and execute quality standards, inspection processes, test methodology, quality plans, documents, and reports. then report to
* management on quality issues, trends, and losses.
* The Regulatory Affairs Associate works with the executive of Quality Assurance to assure all Medical Devices Products and documentation comply with regulatory requirements for medical device products.
QUALIFICATIONS AND EDUCATION REQUIREMENTS:
* Bachelor’s degree in a related field (Quality or Engineering) with Quality certificate.
* Minimum 5 years’ experience of Related Work Experience in Manufacturing industries.
* Spoken and writing fluently English.
* A current relevant Quality qualification(e.g. ISO 9001 Auditor Certificate or equivalent).
* Full conversant with international Quality standards, codes and industry practices
* Ability to follow SOPs and document accordingly.
To apply for this job please visit enayah.com.