Andy Aykazyan
Summary
Results-oriented Quality Assurance and Regulatory Affairs professional with over 15 years of experience in the Medical Device industry, including combination products and In Vitro Diagnostic (IVD) Devices. I’m adept at problem solving with a keen eye for identifying root-cause. I’m highly motivated, with a proven track record of improving product quality, customer satisfaction and ensuring compliance to all regulatory requirements.
- Quality Management System creation, maintenance, and improvement in accordance with FDA, EU, Health Canada, Japan, Brazil ANVISA, MDSAP requirements.
- Excellent grasp of quality systems, statistics, standards, and regulations.
- Superb organizational and Project Management skills. Excellent at multi-tasking and managing timeliness of project milestones.
- Results-driven team leader who understands the value of empowerment for driving continuous improvement and meeting organizational goals.
- Expert in implementing simple and efficient systems that adhere to regulatory requirements, ensure patient safety and lead to better business outcomes.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Quality Systems Program Manager
Medtronic
Northridge, CA
03.2015 - Current
- Defines, implements, and sustains transformation initiatives within the Diabetes Quality Improvement Program, including implementation of Lean methodologies and tools to increase efficiencies in Quality Systems, Manufacturing Processes and New Product Introductions (NPI)
- Leads quality initiatives to develop and maintain a high performing, efficient, effective, and compliant Quality System
- Leads audit and inspection preparation, resolution of audit and inspection findings
- Leads CAPA Projects tied to non-conformances identified internally and externally (FDA 483 Resolutions)
- Coordinates with auditing groups and inspectors through all stages of the audits
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance
- Leads, directs, and reviews the work of team members
- Establishes daily tasks for successful program execution
- Establishes program objectives, timelines, milestones, and budgets.
Quality Systems Manager
Medtronic
Culver City, CA
03.2017 - 06.2020
- Managed daily activities for Quality Assurance staff
- Ensured the site is compliant with all regulatory requirements and standards
- Successfully defended the quality system during inspections and audits (21CFR820, MDSAP, ISO 13485, ISO 14971) Implementation and maintenance of Quality System documents to increase regulatory compliance and to enhance efficiency of manufacturing operations
- Worked closely with Manufacturing to increase quality awareness and identify improvement initiatives
- Coordinated cross-functionally across the organization to ensure successful introduction of new products to market, with FDA 510 clearance
- Led site’s Risk Management activities (in accordance with ISO 14971) for the evaluation of current and new products/processes
- Streamlined complaint handling process for the site
- Collaborated cross-functionally to ensure timely and effective closure of customer complaints
- Identified key process inputs to reduce the number of open complaints by 80%
- Applied Lean Six Sigma methodologies to identify true root cause for top failure modes associated with customer complaints and to implement effective corrective and preventative measures
- Led to reduction of product returns by 75%
- Led site’s corrective and preventive action (CAPA) Board
- Managed the internal and supplier audit processes for the site
- Managed incoming and final inspection activities to ensure suitability of sampling plans and testing methods.
Sr. Quality Engineer
Medtronic
Culver City, CA
03.2015 - 03.2017
- Re-organized site’s calibration and preventative maintenance (PM) program to ensure adherence to regulatory standards and manufacturing requirements
- Implemented Supplier Management Module for the site
- Created Approved Supplier List for the site
- Implemented site’s master validation plan
- Led validation evaluation activities to ensure all validations are up to par with Medtronic and applicable regulatory requirements
- Worked closely with the Purchasing department to qualify new suppliers and monitor existing ones
- Collaborated with key suppliers to significantly reduce incoming inspection failure rates
- Utilized Statistical Process Control (SPC) tools to identify abnormal trends (spikes) in key manufacturing outputs
- Re-organized incoming inspection activities for the site to minimize inspection costs based on risk and improve incoming inspection methods for better detection
- Implemented Dock-to-Stock program for the site.
Sr. Quality Engineer
Siemens Healthcare DX
Los Angeles, CA
08.2008 - 03.2015
- Maintained and supported the Quality Management System activities of Medical Device and Reagent Manufacturing business unit of Diagnostics (IVD)
- Conducted risk assessments (FMEAs) and worked independently to write and execute validation protocols (IQ/OQ/PQ)
- Wrote validation reports
- Qualified key manufacturing processes and equipment to ensure reliable output of products
- Managed the Metrology function for the site
- Led calibration and preventative maintenance activities for Medical Devices and 600+ instruments used in the manufacturing process
- Reviewed and approved engineering change orders for accuracy, completeness and compliance with internal and regulatory Medical Device guidelines
- Maintained Risk Management Files for the site by coordinating periodic risk reviews of existing products
- Actively participated in CAPA review board
- Highly capable in identifying Root Cause
- Incorporated process improvements to enhance overall production efficiency and to meet customer demand
- Worked globally to drive newly developed Worldwide Quality Systems (Intra-Company)
- Served as a multi-functional team leader for quality improvement teams assuring commitments and objectives are achieved with positive results.
Manufacturing Engineer
Siemens Healthcare DX
Los Angeles, CA
08.2008 - 05.2011
- Applied quality improvement initiatives by using improvement Lean Manufacturing Techniques such as Point Kaizen, Kanban and 5S to enhance the overall productivity and safety of laboratory/manufacturing processes
- Implemented Kanban and Pull Systems
- Actively participated in continuous quality improvement initiatives, including the revision and introduction of new Batch Records/SOPs to ensure conformance to quality specs and regulatory standards
- Conducted in-process and final evaluation of products using various laboratory instrumentation and techniques such as Mass Spectrometry (HPLC), Gel Electrophoresis and ELISA
- Utilized statistical tools (regression analysis, method comparison) to qualify immunoassay analyzer kits
- Demonstrated proficiency in troubleshooting and interpreting results
- Cross-trained team members on key processes to simplify the manufacturing flow.
Research Associate
Iris International
Chatsworth, CA
10.2006 - 08.2008
- Followed Good Laboratory Practices (GLP) to perform incoming and final testing of newly developed product
- Successfully performed skilled bench-work and collected data while maintaining a high degree of accuracy and reliability
- Actively participated in ongoing research to introduce new products to market
- 510K clinical submissions for Medical Devices (I-Chem Velocity 2000).
Quality Analyst (Contract)
Baxter Bioscience
Thousand Oaks, CA
07.2005 - 03.2006
- Followed cGMP and regulatory guidelines for the manufacture of plasma derived recombinant coagulant, Factor VIII
- Used expertise to follow Standard Operating Procedures (SOP’s) for performing incoming and final inspection of finished product
- Demonstrated accurate and precise work through the adept usage of laboratory equipment and the ability to perform skilled bench work.
Skills
- Quality Control
- Quality Assurance
- Project Management
- Regulatory Affairs
- Project Management
- Quality Systems
- ISO 13485, 21CFR820, MDSAP, ISO 14971
Education
Master of Science (MS) in Quality Assurance, California State University, Dominguez Hills, 2015
Bachelor of Science in Biochemistry, California State University, Los Angeles, 2006
Publications
Successful Implementation of Lean through the Effective Use of Employee Training, Empowerment and Workplace Ergonomics, ProQuest-CSA, CSUDH, 2015.
Certification
Regulatory Affairs Certification (RAC-DEVICES) -RAPS Cert #122400 (2024)
Project Management Professional (PMP) – PMI –Cert #18909 (2023)
First Time Quality (FTQ) Coach – Medtronic (2022)
Certified Six Sigma Black Belt – ASQ –Cert #18909 (2019)
Certified Quality Auditor – ASQ – Cert # 66340 (2018)
Certified Quality Engineer – ASQ –Cert # 99171 (2017)
ISO 13485:2016 Lead Auditor (TPECS) – BSI –Cert # 8852024-180763
ISO 14971 Risk Management for Medical Devices, Oriel – STAT A MATRIX
Timeline
Quality Systems Manager
Medtronic
03.2017 - 06.2020
Quality Systems Program Manager
Medtronic
03.2015 - Current
Sr. Quality Engineer
Medtronic
03.2015 - 03.2017
Sr. Quality Engineer
Siemens Healthcare DX
08.2008 - 03.2015
Manufacturing Engineer
Siemens Healthcare DX
08.2008 - 05.2011
Research Associate
Iris International
10.2006 - 08.2008
Quality Analyst (Contract)
Baxter Bioscience
07.2005 - 03.2006