Quality Assurance Technician
Resume:
MARK ANGELO PEREZ
**** *** ******* *** *******, CA. 94580 CELL 510-***-****
EMAIL: ****.**********@*****.***
OBJECTIVE: Opportunity to work in environment where my experience and leadership skills can be utilized to develop a high quality and highly efficient product, providing growth, expansion of skills and training for new capabilities.
QUALIFYING SKILLS
Proficient in MS office application: Word, Excel, PowerPoint
Good customer Service
Able to work in fast pace Setting
Ability to work under pressure and meet deadlines
Team player, attention to detail, hardworking and able to meet to multiply task
Three to five years related experience in the medical device industry.
Strong Knowledge of a wide variety of inspection and test equipment and methodologies.
EXPERIENCE:
Bioventrix Inc. 08/2015-Present
Quality Assurance Technician
General Description
Quality technicians are responsible for conducting testing procedures during manufacturing processes to ensure that products comply with quality standards.
Responsibilities
Perform inspection and test activities to include; incoming inspections, in-process inspections, final inspection (packaging/labeling) and lot release
Review and release Sterile Loads
Review and release LAL test results
Perform LHR reviews and other QA related activities as assigned.
Perform and complete First Article Inspections and supporting documentation
Manage calibration program, including scheduling measurement and test equipment for calibration, review of calibration certificates, updating calibration records and establishing equipment files for new equipment
Perform inspection on prototype products, fixtures and components for R&D.
Perform inspections and tests on validations (packaging, shelf life studies, process) to support R&D
Support R&D in the inspection and testing of design verification products
Support improvement initiatives, specifically in updating and standardizing LHR and MPI formats
Provide feedback to management on the quality system processes (incoming, in-process, post-sterilization, FG release) for consideration in continuous improvement
Penumbra Inc. 10/2013-2015
Quality Control Inspector II
General Description
Within the Quality Department, the QC Inspection function is to provide group support inclusive, but not limited to, inspection and testing and to provide training to other inspectors.
Responsibilities
Maintain compliance with GMP’s, Quality Manual, Standard Operating Procedures, Work Instructions and company standards
Support daily inspection activities within respective Quality Department / group*
Read, understand, and interpret engineering specifications*
Support R&D and Manufacturing inspection activities using basic knowledge of inspection techniques and tools/equipment
Use sampling methodologies and techniques
Pass or fail in-process product by confirming specifications; conducing visual and measurements tests; communicating required adjustments to supervisor*
Take measurements using micrometers, calipers, snap gage, gage pins and other measuring instruments*
Document inspection results by completing records and logs
Recognize non-conformances and appropriately initiate and communicate those non-conformances
Provide suggestions and feedback for quality inspection improvement (e.g. test methodologies / instrumentation / fixtures)
Maintain safe and healthy work environment by following safety guidelines and procedures
Support departmental training activities
Comply with quality system regulations, standards and procedures*
Penumbra Inc, Alameda, CA. 01/2012-09/2013
Medical Assembler III
Maintain compliance with GMP’s, Quality Manual, Standard Operating Procedures, Work Instructions and company standards
Perform a wide variety of tasks and processes that are required to build, assemble, inspect, and package products in a controlled manufacturing environment using microscopes, soldering iron and small-handled tools to build high quality medical products.
Record information on lot history records and perform component accountabilities.
Perform verifications of manufacturing operations and line clearances for other assemblers.
Train other assemblers in device assembly and document review.
Satiety Inc, Palo Alto, CA. 03/2009–12/2011
Material Handler
Transacted materials for production using QAD systems which also supported Shipping & Receiving, as well as Inventory Control Department
Provided materials for manufacturing, also pulling kitts for production
Filed DHR for Document Control, invoice and material transfer forms
Supported other department such as Manufacturing Engineering, R&D Engineering, Sales Team, Marketing Department, HR, Clinical Team
Wal-Mart, San Leandro, CA. 01/2008-02/2009
Service Clerk/Online Store/Material Coordinator
As a service clerk to provide friendly customer service, courteous and efficient service to customers.
Responsible Improving online sales on daily base, cycle count, inventories merchandises.
Responsible for merchandise in warehouse/online store, include store inventory and products ordering.
Experienced in the Shipping and Receiving process; Experienced in kitting work orders.
Experienced in parts cleaning and packaging
Knowledge of QAD System to do all Transaction material; Responsible for Issued Work Order; Close Work Order,
VOLUNTEER / COMMUNITYEXPERIENCE
Youth Activities Coordinator, Manor Baptist Church, San Leandro, CA.
Leading a group of (20-30) Children that attend the Church for different activities during Church session and summer breaks.
EDUCATION: Chabot College, Hayward, CA. General Study.
Arroyo High School, San Lorenzo, CA. Graduated
REFERENCE:
Ted Condez
Associate Director Quality Engineering
Intarcia Therapeutics, Inc
*********@*****.***
Scott Baldwin
Senior Director Quality
Bioventrix, Inc
******@***.***
Rovil Arcia
Senior RND Project Manager
Veniti
************@*****.***
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