Quality Assurance Manager - Medical Devices
Enteplin -
10th of Ramadan City, CairoPosted 5 years ago96Applicants for1 open position
- 23Viewed
- 1In Consideration
- 5Not Selected
Job Details
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Job Description
Key Responsibilities:
- Supports and reviews quality systems processes and serves to improve awareness, visibility, and communication on quality initiatives to support assigned quality goals and priorities..
- Reports to CEO to create new Quality System procedures/instructions.
- Monitor and maintenance of existing processes.
- Managing internal and external audits and maintaining schedules and records
- Including tracking CAPA activities as required.
- Assist in and prepare for the execution of Notified Body audits and track progress of responses.
- Assist in investigating quality issues and interact with products suppliers regarding these.
- Review and investigate customer complaints, determine product failure root causes and evaluate risk of failures.
- Ensure that the quality system is understood and applied throughout the organization on all levels by personnel concerned.
- Authorizing product release to stock and completion of relevant records upon receipt.
- Maintenance of technical files, OBL files and test reports of product conformity according to MDD 93/42/EEC and amendments (be aware of the latest regulation).
- Assist with international product registrations.
Job Requirements
- Experience preference should be in medical devices 3-5 years.
- QA manager must have a suitable bachelor degree and experience in both ISO 13485 & medical device regulations (MDD 93/42/EEC and amendments) and Regulatory affairs.
