David Affonseca Jr. Email & Phone Number
Director of Quality Assurance @ Axoft
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David Affonseca Jr. Location
- Boston, MA, US
David Affonseca Jr. Work
- Director of Quality Assurance @ (February 2025 - Present)
- Quality Assurance Manager @ (September 2024 - Present)
- Director of Quality Engineering @ (August 2022 - December 2023)
- Director Of Quality Assurance @ (February 2020 - September 2022)
- Director of Quality Assurance and Regulatory Affairs at Photo Diagnostic Systems @ Photo Diagnostic Systems (December 2010 - February 2020)
- Quality Assurance Manager @ (January 2007 - December 2010)
- Manager, Quality Assurance and Document Control @ angioLINK Corp. (Acquired by Medtronic) (May 2001 - February 2007)
David Affonseca Jr. Education
- Roger Williams University
Associate's degree (Mechanical Engineering)
1993-1995 - Roger Williams University
BS (Industrial Engineer/Managerment Concentration)
1999
David Affonseca Jr. Skills
- Auditing
- Biocompatibility
- Biologics
- Budgeting
- Business Process Improvement
- Business Transformation
- CAPA
- CMC Regulatory Affairs
- Calibration
- Cause & Effect
- Championing Change
- Change Control
- Change Management
- Clinical Monitoring
- Clinical Trials
- Communication
- Complaint Handling
- Compliance
- Compliance Management
- Continuous Improvement
- Customer Service
- Design Control
- Design of Experiments
- Document Management
- Documentation
- Employee Training
- Engineering
- FDA
- FDA GMP
- FMEA
- Financial Goals
- GMP
- Global Regulatory Compliance
- Good Clinical Practice (GCP)
- ISO 13485
- ISO 14971
- ISO 17025
- ISO 9001
- Industry standards
- Injection Molding
- Inventory Control
- Key Performance Indicators
- Lean Six Sigma
- Management
- Manager of Managers
- Manufacturing
- Manufacturing Operations
- Medical Device R&D
- Medical Devices
- Minitab
- NCMR
- Oncology
- Operations Management
- Organization Skills
- Performance Metrics
- Performance Oriented
- Preventive Actions
- Problem Solving
- Process Auditing
- Process Development
- Process Validation
- Product Development
- Professional Phone Skills
- Program Management
- Project Management
- Project Planning
- Proposal Support
- Protocols & Reports
- QSR
- Quality Assurance
- Quality Auditing
- Quality Control
- Quality Engineering
- Quality Management
- Quality Operations
- Quality Risk Management
- Quality Systems
- R&D
- Regulatory Affairs
- Regulatory Submissions
- Risk Management
- SPC
- Scope Management
- Shipping & Receiving
- Standard Work
- Start-up Ventures
- Statistics
- Sterilization
- Strategic Initiatives
- Strategic Planning
- Supplier Quality
- Supply Chain Management
- Team Building
- Team Leadership
- Teamwork
- Testing
- V&V
- Validation
- Visio
- cGMP
- ISO
- CE marking
- Process Improvement
- Microsoft Office
- Aseptic Processing
- Start Up Ventures
David Affonseca Jr. Summary
- David Affonseca Jr., based in Boston, MA, US, is currently a Director of Quality Assurance at Axoft. David Affonseca Jr. brings experience from previous roles at Axoft, Lumicell, Ultra Maritime and Photo Diagnostic Systems. David Affonseca Jr. holds a 1993 - 1995 Associate's degree in Mechanical Engineering @ Roger Williams University. With a robust skill set that includes Auditing, Biocompatibility, Biologics, Budgeting, Business Process Improvement and more. David Affonseca Jr. has 4 emails and 1 mobile phone numbers on RocketReach.
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