Quality Assurance Medical
Resume:
Manal Hanna
**** ***** ***, ***** ****, CA *****
acx138@r.postjobfree.com
1
Summary
- Experienced Service Engineer for Medical Instruments with excellent service skills and records of success.
- Management and analysis experience with excellent computer skills & Quality Control and Quality Assurance skills FOR Medical Devices.
- Experienced in Computer, secretary & highly communication skills.
- Experienced broadcasting Engineer with quality control skills for multimedia programs. Qualifications
- Over 23 years of experience within the medical device industry.
- Over 16 years of management experience in Quality Control and Quality Assurance roles
- In-depth knowledge of ISO 9000/9001, and 13485 requirements. Experience
- Standard Operating Procedures Preparing (SOP).
- Flowchart preparing for the process.
- Quality Auditing (as a member of an internal auditing team)
- Corrective and preventive action (CAPA) to eliminate causes of non conformities.
- Good manufacturing practice (GMP)
- Customer complaints analysis.
Manal Hanna
2462 Norse Ave, Costa Mesa, CA 92627
acx138@r.postjobfree.com
2
- Complaints about marketed products are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective products and to prevent recurrence.
- Troubleshoot and resolve quality issues as they arose; Used root cause analysis.
- PDCA cycle (Plane-do-check-act) method for improving the product.
- Develop forms and instructions for recording, evaluating and reporting quality and reliable data.
- Developed product quality specifications based on design objectives and customer input.
Education
1- B.Sc. of Science in Engineering, emphasis in Biomedical Engineering, Cairo University, Cairo, Egypt, November 1991
With a graduation project in Image processing to discover the perfect ways to process these signals using a variety of mathematical formula and algorithm to provide and transmit useful medical image and information without any lost upon which clinician can make decisions 2- Classes in Quality Assurance for medical devices in NOCCCD, Orange County, CA:
- Introduction to Medical Devices Quality Assurance
- Regulatory affairs for medical devices.
- Document and Database Management for Medical Devices.
- Quality Assurance for Medical Devices.
- Technical writing for Bio medical industries.
- Quality Auditing for Medical Devices.
Manal Hanna
2462 Norse Ave, Costa Mesa, CA 92627
acx138@r.postjobfree.com
3
Work Experience
1992 – 2012 Audiology Department Manager, Bardissi Medical, Cairo, Egypt
- Started as a biomedical engineer within the repairing department in 1992 in the Middle East achieving a senior level in 1994, and was promoted to the service supervisor in 1996, then manager in 1998.
- Responsible for maintaining quality control for the repaired devices, the custom made hearing instruments (production) in accordance with company and regulator standards.
- Analyze d customer complaints and issued CAPA’s (Corrective and preventive actions).
- Troubleshoot and resolve quality issues as they arose; Used root cause analysis.
- Develop forms and instructions for recording, evaluating and reporting quality and reliable data.
- Participated in internal quality and vendor quality system audits.
- Responsible for maintaining compliance with ISO 9000, 9001 requirements.
- Participated in process validation activities.
- SOP document (standard Operation Procedure).
- Responsible for repairing & custom made instruments production quality for the Middle East.
- Provide high performance and support to keep the standardization for the quality requirements 2013 – Present Quality Control and Broadcasting Engineer, Media Dream, Huntington Beach, CA
- Responsible for the quality control of all live programs, recorded programs & the production.
- Trouble shooting technical issues during broadcasting.
- Issued corrective actions and preventive actions to maintain quality.
- Deal with the emergency situation of the system during the Live programs. Manal Hanna
2462 Norse Ave, Costa Mesa, CA 92627
acx138@r.postjobfree.com
4
Training Courses:
1- Cochlear Implantation Programming & repairing
2- Repairing for audiology medical devices (Siemens) 3- Repairing Infant Medical Incubators (Air Shield) 4- Auditing & Quality Control ( ISO 9000/9001)
5- Communications skills
6- Management and analysis skills
7- Broadcasting skills & quality control skills in media programs 8- Some classes in USA related with the quality assurance for medical devices.
- Introduction to Medical Devices Quality Assurance
- Regulatory affairs for medical devices.
- Document and Database Management for Medical Devices.
- Quality Assurance for Medical Devices.
- Technical writing for Bio medical industries.
- Quality Auditing for Medical Devices.
Computer Skills
- Microsoft Word, Excel and Power Point. Flash, Internet Other Skills
- Positive attitude with good decision -making skills
- Ability to handle multiple tasks with excellent organizational skills.
- Ability on making a professional power point presentation for any subject
- Ability on finding out, understand any new material related to any new subject by myself through searching on the internet
- Ability to learn, work in a team, and individually as well Language Skills
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