Robert Bob Black Black

About Robert Bob Black Black

SUMMARY • Reputation of being a change agent in Quality and Regulatory Compliance.• 22 years of Quality experience, QSR (21 CFR 820), Medical Device Directive (MDD) and ISO 13485, with medical device manufacturers of 510K, PMA and IVD devices.• Strong ability to maintain open, cooperative relationships with internal/external customers. Strong verbal, analytical, written and computer skills.• Superior performer with limited supervision. PERSONAL QUALITIES • Dedicated, detail oriented and organized professional who is focused on Quality.• Creative and conscientious individual who enjoys working as a team member.• Self-starter with proven ability to solve problems with complicated issues.• Mature individual with a unique blend of experience and organizational expertise to meet the challenges of a growing, changing, and fast paced company.• Excellent communication, interpersonal, and personnel management skills.• An organized, self-improvement seeker with the ability to manage multiple high-profile priorities to meet critical deadlines. STATEMENT OF QUALIFICATIONS • Manage daily activities of QA department. Supervise receiving, in-process and final product inspection and testing.• Supervise receiving inspections in accordance to prints or schematics. Review and maintain quality records. Perform internal and supplier quality system audits.• Create change orders to improve inspection/testing process.• Qualify suppliers and monitor their performance.• Trending and reporting quality metrics to management for review.EDUCATION Biola University – B.S, Organizational Leadership December 2004Palomar College – A.A, General Education June 2002ASQ – Certified Quality Auditor June 2015ASQ – Certified Biomedical Auditor October 2014ASQ – Certified Manager of Quality/Organizational Excellence October 2009OSHA – Certified Forklift Operator January 2001

Experience

1. Asst Qa Manager

   Leidos

   Mar 2024 — Present · Vista, CA, US

   The Leidos Security Enterprise Solutions (SES) team has developed a suite of integrated solutions for aviation, ports, borders, and critical infrastructure customers around the world. We provide automated threat detection for weapons, narcotics, explosives, contraband, and undeclared goods, as well as nuclear and radioactive materials, by leveraging industry leading screening technologies, AI/ML capabilities and advanced biometric tools. We have more than products deployed across 120 countries, including best-in-class security checkpoint and inspection systems for people, checked baggage and more.

Education

• Biola University

  Bachelor's Degree, Organizational Leadership

  2002 — 2004

• University of Washington

  LSSBB Certification, Quality Control Technology/Technician

Skills

• Root Cause Analysis
• Fda
• Spc
• Quality Auditing
• Iso 13485
• Quality System
• Quality Assurance
• Medical Devices
• Capa