Quality Assurance Engineer
Resume:
Jayson Grabowski
*** *** ********* **********, ** 33767
***************@*****.***, 352-***-****
Experience
Independent Contractor Clearwater, FL
Independent contractor providing validation consulting services to medical device manufacturer, evaluating
overall validation program compliance and providing custom validation protocols.
Evaluation of equipment, processes, facilities, sterilization, and cleaning validations to
communicate gaps in the validation program to the manufacturer where validation is required or
existing validations are insufficient and establish a priority for completion of critical items.
Draft validation protocols for execution by customer, assist with execution if necessary, review
execution results documentation, and provide summary reports.
Create Standard Operating Procedures or Work Instructions or review existing procedures for
determining validation need for new equipment and template protocols.
Invuity Inc. San Francisco, CA
Quality Assurance Engineer 04/2010 – 03/2011
Primary Quality Assurance Engineer at a fast paced medical device manufacturer focused on the
development of new, single-use and reusable, products and specialty design devices.
Quality Assurance representative to Product Development team to assure adherence to the
Design Control process, completion of Design History Files prior to design transfer to operations, and
design and execution of product verification and validation protocols.
Management of Risk Management FMEA program for development projects and analysis of
current product FMEA documents to ensure compliance with current regulatory standards.
Revision of internal Quality Manual, MDD and CMDD procedures to bring up to date with most
recent revisions.
Participation in audit as validation subject matter expert and assumed responsibility for oversight
of response to audit findings for successful initial ISO 13485 certification of company.
Quality Assurance supervision of QC and operations personnel during product assembly. Lead in-
process and final product inspection and approval of finished product disposition.
Participation in Material Review Board for non-conforming product and product complaints and
oversight of pending corrective and preventative actions for product disposition.
Participated in process optimization projects to ensure compliance with company Quality Systems
and regulatory requirements.
Oversight of the supplier quality program including SCAR monitoring and creation and
maintenance of Approved Supplier Files.
Created validation documentation program including SOPs and work instructions for sterilization,
packaging, Process PPQ, Equipment IQ/OQ/PQ, and software validations.
Initiated, managed, and approved CAPA’s, including actions generated through customer
complaints and non-conforming materials, reducing open CAPA’s by 75%.
Used risk based approach to define criteria for inspection of incoming materials for new products.
Designed the sterilization program for all sterile products for validation, adoption, and monitoring
and maintenance, and review of sterilization records for finished goods release.
RTI Biologics Gainesville, FL
Product Development Quality Engineer 03/2007 – 03/2010
Validation engineer serving Product Development, R&D, and Operations Departments of a high volume
medical products manufacturer. Provided oversight and training for Quality Engineer validation activities
and primary validation control of all development projects.
Development, approval, and management of execution of validations for new or revised
equipment, sterilization processes, software upgrades, packaging, and new production and shipping
processes.
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Supported the Microbiological Department and QA Environmental Monitoring Lead on clean room
and cleaning processes, identification of monitoring trends, and investigation of adverse trends.
Served as the validation subject matter expert for R&D, Quality Assurance, Microbiology
Department, and Development Engineers and for outside vendor and regulatory audits.
Evaluation of validation packages in response to product and/or process changes to identify
revalidations, or new validations, to ensure compliance.
Performed gap analysis of existing product validation packages to ensure validation requirements
are met and developed and executed validation plans to meet quality requirements.
Maintenance of Validation Master Plans for Facility and Facility Cleaning Processes.
Review and approval of validation non-conformances/deviations and identification of corrective
and preventative actions.
Validation of clean room construction and equipment, facility cleaning, and clean-in-place
processes.
Created standardized validation protocols for different functional groups and developed new
documentation system for identification of validation protocols.
CryoLife Inc. Kennesaw, GA
Sterilization Engineer 03/2005 – 03/2007
Management of sterilization program for tissue bank/medical device manufacturer for finished product and
validation of sterilization of in-process equipment and instruments.
Management of the sterilization program including irradiation, Ethylene Oxide, steam, dry heat,
and chemical.
Validation of reprocessing and sterilization of reusable devices.
Coordination of preparation and delivery of validation samples to outside testing labs.
Spearheaded the identification, purchase, and validation of microbial ID system for microbiology
laboratory.
Develop procedures for microbiology identification system and training of laboratory personnel.
Alpharma / Purepack Pharmaceuticals Elizabeth, NJ
Microbiologist 03/2004 – 03/2005
Microbiologist for large pharmaceutical manufacturer responsible for sampling, testing, and release of raw
materials, product intermediates, and finished drug products.
Quality Control testing of raw materials and purified/water for injection water system.
Isolation and identification of microbial contamination isolated from materials and water.
Execution of validation of new laboratory test methods and equipment.
Nephron Pharmaceuticals Orlando, FL
Validation Specialist 2003 – 03/2004
Microbiology department validation specialist responsible for microbiological sampling and testing of
validation samples and validation of microbiology lab equipment.
Microbiologist representative in validation of clean rooms and clean-in-place processes for aseptic
fill suites.
Management of sterile media fills for aseptic fill processes.
Validation of microbiological methods and quality control testing equipment.
Education
University of Central Florida
B.S. Biology
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