Quality Engineer
Resume:
CHRISTINA CHAO
**** *********, ******* *****, ** 92660 • 510-***-**** • *********.*.****@*****.***
OBJECTIVE
To obtain a position in the biomedical field where I can utilize my work experience and education to improve the company’s quality systems and operations
PROFESSIONAL EXPERIENCE
Penumbra Inc., Alameda, CA April 2012 – Present
Quality Engineer
• Responsible for maintaining and improving quality management system
• Perform root cause investigations and implementation of corrective action for process related concerns (i.e. NCR, CAPA, SCAR, etc.)
• Develop training to build quality awareness
• Support quality inspectors to ensure that products and processes comply with requirements of quality system
• Support catheter and stent-related production lines
• Analyze failure, corrective and preventative action to respond to nonconformance and customer complaints
• Create and maintain quality documentation (i.e. quality manuals, procedures, work instructions, etc.)
• Create test method validations, process verification and validation based on master plans and pFMEA
• Provide continuous improvement of inspection process, procedures, and the overall quality management system
• Conduct audits, which includes creating audit finding reports, determining proper corrective and preventive actions, and closing out audit findings
• Perform SPC investigations and establish statistical confidence by identifying sample size and acceptable error; determining levels of confidence
Fisher & Paykel Healthcare, Irvine, CA July 2011 – April 2012
Quality & Regulatory Specialist
• Responsible for investigating customer complaints for product quality issues and concerns
• Work on complex investigations and coordinate technical teams to ensure compliant experimental design, effective data analysis, identification, implementation, verification and validation of corrective and preventative action (CAPA) and subsequent closure of investigations.
• Prepare and present analysis of complaint data and identify potential quality trends
• Assess customer complaints for potential regulatory reporting
• Devise and implement methods and procedures for inspecting, testing and evaluating product(s)
• Provide inbound technical support for customers by troubleshooting, investigating and resolving customer’s inquiries with Fisher & Paykel products
• Record and process complaints and inquiries which can assist in the tracking and trending of product complaint data for monthly quality reports and Quality Review directed by Quality Management
• Facilitated calibration and maintenance of test equipment to ensure conformity with regulatory standards
• Participate in Product Hold and Non-Conforming Report procedures reviews during internal audit
Neuropsychiatric Research Center, Santa Ana, CA April 2010 – January 2011
Laboratory Research Assistant
• Work directly with a psychiatric population to deliver high quality patient data in accordance with regulations and Good Clinical Practice (GCP) and as required by the study protocol.
• Maintain and update patient charts and patient database.
• Maintain and update electronic Case Report Forms (eCRFs) and respond to and resolve data queries.
• Perform pre-intake evaluations of potential subjects, including obtaining medical and psychiatric history and reviewing eligibility based on inclusion/exclusion criteria.
• Obtain vitals, including blood pressure, heart rate, height, weight, temperature and electrocardiogram (ECG).
• Prepare, package, and ship laboratory specimens. Maintain and update lab inventory and sustain laboratory supplies (visit kits, general supplies, etc.).
RESEARCH EXPERIENCE
Abbott Medical Optics, Santa Ana, CA September 2010 –June 2011
Senior Design Project Leader
• Construct reliable, cost-efficient model of enucleated eye containment apparatus for optic surgery/ medical training purposes
• Create entry level model and showroom model of device
• Test prototype using devised suction inspection and running autoclave cycle
• Produce finished model that supersedes the functionality and efficiency of existing product on market: Mastel Training Box
• Organize and facilitate scheduled meetings to brainstorm and/or implement design plans
• Receive University of California, Irvine, Henry Samueli School of Engineering Dean's Choice Award at Senior Project Design Review
LEADERSHIP EXPERIENCE
Biomedical Engineering Society (BMES) September 2011–Present
Board Executive
• Collaborating- organize meeting agenda and topics of discussion with the president. If necessary, facilitate meeting in the absence of the president and/or vice president. Work with internal and external affairs for networking purposes within the organization. Attend weekly delegate conferences to report current standing(s) of the organization.
Biomedical Engineering Society (BMES) September 2010–June 2011
President
• Appointing and delegating- take great care in the appointments you make and in delegating tasks. After appointing persons to perform tasks, ensure that the task is done.
• Evaluating- on-going analysis of club meetings and operation leads to continuous improvement in the club.
• Problem solving- make it apparent that you are concerned and accessible. Seek input and explore alternatives before making important decisions.
Biomedical Engineering Society (BMES) September 2009– June 2010
Public Relations Officer
• Developing and maintaining the reputation of the organization.
• Promoting the products or services of the organization.
Society of Women Engineers (SWE) September 2008- June 2011
Member
• Actively attending meetings and events
SKILLS
Operating Systems: Windows 2000/XP/Vista/Windows 7
Software: MS Office/Excel/Powerpoint/Outlook, PSPICE, MatLab, SolidWorks, LabView, Minitab, Gage R&R
Language: Fluent in English, Fluent in Chinese (Mandarin, Shanghainese dialect), Conversational Spanish
EDUCATION
Bachelor of Science in Biomedical Engineering, University of California, Irvine March 2012
Minor in Chinese Language and Literature, University of California, Irvine
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