Darlene T.

About Darlene T.

A highly motivated, self-starting professional with a proven track record in OEM and Contract Manufacturing Companies. A quality and global business executive with over 25 years of extensive leadership experience in the medical device, biologics, and combination product industries. Strong communicator with the ability to build relationships among key external and internal stakeholders.Core skills and competencies include:Quality Leadership in the Development and Production of medical device, biologic products in the following areas: Quality System Development and Support, Auditing, Risk Management, Post Market Surveillance, Regulatory Inspections, Warning Letter Remediation, Supplier Management, Regulatory Compliance, Quality Systems, Post Market Surveillance, Incoming Inspection, Change Control, Software Validation / IT Governance, and VAWD certification.

Experience

1. Site Head of Quality, Compliance, and Ce & s

   Getinge

   Apr 2024 — Present · Merrimack, NH, US

   Executive leader of Quality/Compliance, Controlled Environment and Sterilization. Appointed Management Representative and PRRC.

Education

• Southern New Hampshire University

  Masters, Business Management

• Northeastern University

  Courses taken, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs

Skills

• Iso 14971
• Root Cause Analysis
• Regulatory Affairs
• Design Control
• Quality Auditing
• Aseptic Processing
• Validation
• Quality Control
• Iso
• Sop
• Fda
• Gmp
• Medical Devices
• Capa
• Process Improvement
• Auditing
• Manufacturing
• Quality Assurance
• Quality System
• V&V
• Document Management
• Testing
• Change Control
• Quality Management
• 21 Cfr Part 11
• Iso 13485
• Lead Auditor Iso 13485