Derek Wooster

About Derek Wooster

I am a highly motivated and results driven Quality Assurance professional with over 8…

Experience

1. Lead Investigator, Product Surveillance

   Terumo Cardiovascular

   Mar 2018 — Present · Ann Arbor, MI, US

   Conduct complaint investigations in compliance with regulatory standards and company procedures for multiple production sites in and outside the U.S. Collaborate with various departments including customer service, service, field service, technical support, and clinical specialists to ensure thorough complaint investigations.• Execute quarterly Complaint Trending activities as per company procedures. This involves data extraction on product lines, identification of statistical trends, and analysis of these trends with cross-functional team members. Present findings and recommended actions to cross-functional leadership, which included initiating Corrective and Preventive Actions (CAPAs).• Rolled out and established the complaint handling and adverse event reporting processes for a new manufacturing site within the organization. Worked cross-functionally with corporate senior leadership, site management, and quality personnel to implement the new process. Provided oversight on the day-to-day execution of the process to identify continuous improvement opportunities and ensure product quality issues were addressed, tracked, and trended.• Oversaw the Product Surveillance Material Control Center (PSMCC), ensuring the maintenance of quality standards within the group. Provided support to PSMCC direct reports in their daily activities, complaint handling, and problem resolution.• Managed the maintenance of equipment in the Product Surveillance Laboratory, ensuring that all equipment was properly maintained according to appropriate calibration and preventative maintenance schedules.

Education

• Michigan State University

  Bachelor of Science (BS), Packaging Science

  2010 — 2014

• Detroit Catholic Central High School

  General Studies

  2006 — 2010

Skills

• Packaging Design
• Microsoft Project
• U.s. Title 21 Cfr Part 820
• Microsoft Powerpoint
• Iso 13485
• Iso 11607 Parts I & Ii
• Customer Service
• Teamwork
• Continuous Improvement
• Qualification
• Clear & Concise Communication
• Artioscad
• Capa Initator/Evaluator
• Failure Mode and Effects Analysis (Fmea)
• Blueprint Pcm
• Corrective and Preventive Action (Capa)
• Engineering
• Ista 7d
• Minitab
• Elhr
• Sqllims
• Jmp Statistical Analysis Software
• Fssc 22000
• Adobe Illustrator
• Viewpoint
• Adobe Photoshop
• Food Safety
• Leadership
• Gmp
• Microsoft Office
• Teamcenter
• Packaging
• Microsoft Onenote
• Time Management
• Quality Assurance
• Microsoft Word
• Manufacturing
• Microsoft Excel
• Powerpoint
• Statistical Process Control (Spc)