Alexander Vaizburd
Senior Quality Engineer
San Diego,CA
Summary
A seasoned Senior Quality Engineer with over 15 years of experience in Quality Engineering and Program Management. Adept at guiding large-scale programs in Medical Device Manufacturing and Regulatory Compliance, with a focus on risk management, to ensure organizational success and customer satisfaction. Track record of driving strategic direction and exceeding expectations.
Overview
15
15
years of professional experience
3
3
years of post-secondary education
Work History
Senior Quality Engineer
Modular Medical
San Diego, CA
12.2022 - 02.2023
- Successfully collaborated with program teams to deliver high-quality products on schedule
- Provided Design Assurance and Quality Engineering support for new products, design modifications, and manufacturing transfers
- Led the development of design test and inspection methods, as well as validation activities, ensuring regulatory compliance and completeness of DHF content
- Facilitated risk management activities from product conception to commercialization and promoted quality, reliability, and compliance with standards and regulations
- Managed CAPA projects from start to finish and developed and monitored quality metrics to maintain compliance and improve efficiency
- Assisted in the definition of component specifications, development of sampling plans, and vendor qualifications, conducting supplier audits as required
- Adhered to regulatory requirements, company policies, and operating procedures while exercising judgement in planning and organizing work
- Maintained positive communication and collaboration with employees, customers, contractors, and vendors.
Senior Quality Engineer
Philips Respironics
Carlsbad, CA
11.2019 - 01.2023
- Managed the Quality Engineering and Calibration Program for the Philips Healthcare Business Division and Production Facility, ensuring regulatory compliance with the FDA related to class III medical device manufacturing and validation
- Audited and developed protocols in alignment with company quality standards, 21CFR820, ISO 13485, ISO 14971, ISO 17025, and ISO 9000 regulations
- Provided engineering support and led troubleshooting activities on the production line, performing systematic and documented Root Cause Analyses and implementing Corrective Actions
- Collaborated with the Product Development team to ensure Design Transfer activities were in compliance with the quality management system and external regulatory agencies
- Ensured product standards were documented and compliant, performing quarterly gap analysis and reviewing verification documentation
- Developed and maintained design history files for all assigned projects, adhering to FDA required design control procedures and performing periodic reviews to assure timely design transfers
Quality Engineer
United States Navy
San Diego, CA
12.2007 - 11.2019
- Successfully managed the Engineering/Metrology and Calibration (METCAL) Program for the United States Navy, overseeing 85,000 precision measurement assets valued at $195 million and supporting 192 production departments for Medical and Aerospace and Defense
- Established expert-level knowledge and served as a subject matter expert to industry professionals and consumers worldwide, ensuring traceability of individual measurement results to accepted references
- Analyzed statistical data and developed quality procedures and controls, leading to successful early deployment and completion of mission requirements before critical deadlines
- Directly accountable for maintaining operational readiness and capability for the Engineering program.
Education
Certificate - Engineering
Navy Engineering Academy
United States 01.2008 - 01.2011
Lean Six Sigma Green Belt -
United States Navy
05.2001 -
High School Diploma -
Santaluces High School
Lake Worth, FL 05.2001 -
Skills
ISO 13485, 14971,17025, 9000:1, 21CFR820
Timeline
Senior Quality Engineer
Modular Medical
12.2022 - 02.2023
Senior Quality Engineer
Philips Respironics
11.2019 - 01.2023
Certificate - Engineering
Navy Engineering Academy
01.2008 - 01.2011
Quality Engineer
United States Navy
12.2007 - 11.2019
Lean Six Sigma Green Belt -
United States Navy
05.2001 -
High School Diploma -
Santaluces High School
05.2001 -