Robert James Wixey

Quality and Aviation Professional

Confident and dependable professional dedicate to providing superior service to aviation, medical device and customer service industry as an individual contributor management roles.

Experience

Skills

Prime Flight Aviation services Feb 2023 to current date

Baggage Handler Agent

SIDA Certification San Diego International Airport

Provide supporting services for United and Alaska Airlines

Inovio Oct 2013 to Jan 2022 with roles covering QC/QA, Quality Assurance Specialist, Lead auditor, Supervisor of Compliance and Manager of compliance.

Manage internal audit program. Led gap analysis and QM updates for ISO13485:2016.

Successfully led notified body inspections resulting in no major or critical findings. Implemented audit utopia, improving inspection readiness, communication, request for records and a comprehensive record of each inspection.

Manage monthly product quality metrics meeting to increase monitoring and measuring of product and processes.

Conducted due diligence audit of UPS HealthCare global distribution partner.

Manage corrective and preventative action program. Update procedure to incorporate ISO 14971 risk assessment for probability of occurrence and severity.

Conduct Annual GMP Training and GMP Jeopardy! An interactive team building game created to make quality fun!

Customer Complaint coordinator. Implemented enterprise system to improve feedback, adverse event determination, and customer complaint reporting.

Cytori Therapeutics March 2010 to Oct 2012 Quality Assurance Specialist

Maintain GMP training program, revised database to link document and revision number, reduce data entry errors and improved employee accountability leading to an improving on time training from 76% to 97%.

Maintained calibration and maintenance program, implemented new metrology supplier and equipment software leading to reduced supplier errors, improved equipment traceability and loss prevention.

Cardio Net Oct 2008 to Aug 2009 Quality Assurance Associate

Manage feedback and customer complaint program for high volume portable heart monitor manufacturer. Maintained objective of closing complaints within 60 days.

Premier Loan Closures 2003 to 2007 Owner Operator

Notary Public

LXN, a J&J company Dec 1999 to Sept 2002 Quality Assurance Specialist

Document Control Coordinator

Calibration and Preventative Maintenance Coordinator

Contact information

4322 35th Street

San Diego CA 92104

619-***-****

adyvt8@r.postjobfree.com

Sound interpersonal communication and customer service skills applicable to a broad range of opportunities in regulated industry.

Proficient with all aspects of medical device quality management systems including customer complaints and CAPA

Leadership skills aimed towards accomplishing tasks ahead of schedule and maintaining departmental and corporate goals.

Proven creative problem-solving capabilities

Supporting regulated industry

Aviation

Supporting CFR 14 and 49

Medical Device and Combination Products

Proficient with CFR 820, 803, 210, 211, part 4, part 11, ISO 13485:2016, ISO 14971:2019, ISO 11137-1, MDSAP and MDR

Enterprise Software, Master Control, Smart Solve,, AX 4 Pharma 365, MAS and Macola, Adaptive Compliance Engine (ACE) and Audit Utopia, Jira and Redmine

Certified ISO 13485:2016 Lead Auditor TPECS

Medical Device Quality Management Systems MD

Management System Auditing AU

Leading Management System Audit Teams TL

Education

Century Business College, 1991 to 1992

Associate degree

Business Administration

Food and Beverage Management and mixology

Mission Bay High School

Graphic Arts

Communication

*References available upon request*

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