MEHMET SERTAC SERDAROGLU Phone# 972-603-8294 :: Plano, TX
OBJECTIVE
Seeking for a challenging and rewarding position in Quality Engineering – Medical Device in an esteemed organization to use my expertise in the complex fields of quality assurance operations to evaluate and create unique solutions that may arise.
SUMMARY OF QUALIFICATIONS
• Excellent understanding of Risk Management, QSR, cGMP, 21 CFR 820, ISO 13485, EU regulatory compliance requirements such as 93/42/EEC, 90/385/EEC:2007 AIMD Active Implantable Medical Devices Directive and the Australian Medical Devices Guidance Document Number 23: The Essential Principles for Medical Devices that govern development of medical products as well as their safe use in the health care.
• Ability to perform engineering skills by in-depth knowledge of the use principles of science, mathematics, statistical techniques and quality control process sampling systems, procedures and bioengineering to design, implement, and evaluate hardware and software solutions to bioengineering related issues.
• Skilled in generating written documentation in the form of protocols, Risk Management documents (Design FMEA, Application FMEA, Hazard Analysis, Risk Management Report), Essential Requirements and Principles Checklists, protocols, validation and verification reports.
• Established expertise in the data analysis, maintenance and operations of facilities in compliance with applicable, specifications, regulatory codes, safety standards and operating procedures for medical products.
• Ability to interpret and evaluate Lean Six-Sigma analyses and document of government and industry standards, product specifications or processes of their accuracy and precision and recommend corrective action if necessary.
SKILLS
• Great inter-personal skills; and comfortable working effectively both independently and in a team environment.
• Excellent communication (both written and verbal) and organizational skills and strong attention to details
• Established expertise in MS office, Windows Vista/2000/7, ANOVA, Minitab and some languages including MatLab, C++
• Established knowledge in QSR, cGMP, CAPAs, Complaint investigations, PLM, Adverse Health Outcomes (AHOs) and quality management standards including BS EN 45502-1:1998, BS EN ISO 14971, ISO 13485, IEC 60601:2005, BS EN ISO 10993-1, 90/385/EEC:2007 AIMD Active Implantable Medical Devices Directive, and Australian Medical Devices Guidance Document Number 23 The Essential Principles for Medical Devices
• Able to do process documentation, generating engineering reports and analysis with FDA and/or European based regulations and design control, change control, QC, manufacturing & inventory processes to identify process improvements and material problem purpose
• Critical thinker, analytical problem solver while overseeing multiple tasks for several projects or base business deliverables
• Hard and independent worker and able to work under pressure
WORK EXPERIENCE
St. Jude Medical, Plano, TX - Sylmar, CA – Portland, OR (10/12 – Present)
External Quality Engineer
• Monitored facility and implemented Quality systems for products in accordance to cGMP and ISO 13485.
• Ensured that Quality Assurance standards as well as Design Controls have been properly implemented to ensure that anticipated products and product changes are clearly defined and documented and that resulting design objectives are met throughout the product life cycle.
• Provided technical and management support to CAPA and Design Controls and resolved all related quality issues by implementing root cause analysis and providing statistical information gathered from complaint investigations (Risk Assessment).
• Involved in creating Risk Management Plans, Quality Plans, Design and Application FMECAs, Hazard Analysis, and Risk Management Reports (whether or not based on CAPA related) for the existing and new products for Class III medical devices based on guidance from BS EN ISO 14971 and 21 CFR 820.
• Worked with the regulatory body and PMO to ensure project specification met the customer and product requirements with appropriate standards.
• Created and/or updated Essential Requirements and Principles Checklists for the company’s products via following Active Implantable Medical Device Directive 90/385/EEC:2007 Essential Requirements Checklist and the Australian Medical Devices Guidance Document Number 23: The Essential Principles for Medical Devices. BS EN 45502-1 was also followed to populate these documents.
• Created a work instruction for Essential Requirements and Essential Principles Checklist for standard compliance for notified bodies such as TUV.
• Provided Quality Engineering DHF deliverables, guidance a...
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