Tracy W
Site Head of Quality, Associate Director, Quality at Boston Scientific | Cedar Park, Texas, United States
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Tracy W. currently serves as the Site Head of Quality and Associate Director of Quality at Boston Scientific, a pivotal role that underscores her extensive expertise in the medical device industry. With over 20 years of hands-on experience in quality and manufacturing engineering, Tracy has established herself as a key player in ensuring compliance with stringent regulatory standards, including ISO 13485 and U.S. Food and Drug Administration (FDA) requirements. Her transition to Boston Scientific followed the company's acquisition of Apollo Endosurgery in 2023, where she has been instrumental in integrating quality systems and processes to enhance product safety and efficacy.
In her current role, Tracy leads a dynamic team focused on continuous improvement initiatives and robust quality management systems. She is deeply involved in critical projects that emphasize product specification, verification and validation (V&V), and root cause analysis, ensuring that all medical devices and combination products meet the highest standards of quality and performance. Tracy's collaborative approach fosters a positive team environment, enabling her to effectively drive cross-functional projects that align with business objectives and regulatory compliance.
Her commitment to excellence is evident in her strategic oversight of quality assurance processes, where she leverages her project management skills to streamline operations and enhance product reliability. Tracy’s ability to navigate complex challenges in the medical device landscape, combined with her proactive mindset, positions her as a respected leader within Boston Scientific and the broader industry. Her dedication to quality not only safeguards patient safety but also contributes to the company's reputation for delivering innovative healthcare solutions.
Site Head of Quality, Associate Director, Quality at Boston Scientific in December 2023 to Present
Director Of Quality at Apollo Endosurgery in September 2018 to December 2023
Quality Systems Manager at Apollo Endosurgery in April 2017 to September 2018
Manufacturing Engineering Manager at HealthTronics, Inc. in July 2013 to April 2017
Senior Quality Engineer & Project Manager at HealthTronics, Inc. in December 2010 to July 2013
Senior Quality Engineer, Product Development and Product Performance at Abbott in November 2004 to December 2010
Software Verification Test Engineer at Abbott in June 2003 to November 2004
Engineering Professional Development Program (EPDP) Graduate at Abbott in December 2000 to June 2003
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Pivot Tables
Attention to Detail
Engineering Management
Product Specification
Directing Others
Professional Skills
CAPA
FDA
Quality System
ISO 13485
Medical Devices
Design Control
Quality Assurance
SPC
V&V
Validation
Sterile Packaging
Quality Auditing
ISO 14971
Root Cause Analysis
Testing
Design of Experiments
FMEA
R&D
Product Development
Risk Management
Supplier Quality
Lean Manufacturing
Quality Control
Biotechnology
21 CFR Part 11
Manufacturing
Continuous Improvement
DMAIC
Kaizen
CQE
Quality Systems
FDA GMP
21 CFR
GMP
Sop
Sterilization
Process Improvement
RoHS
Project Management
Product Management
SOP
Manufacturing Engineering
Management
Engineering
ISO
Corrective and Preventive Action (CAPA)
U.S. Food and Drug Administration (FDA)
Cross-functional Team Leadership
Verification and Validation (V&V)
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Discover more about Boston ScientificWhat is Tracy W email address?
Email Tracy W at [email protected] and [email protected]. This email is the most updated Tracy W email found in 2026.
What is Tracy W phone number?
Tracy W phone number is +15128005063 and +15128005064.
How to contact Tracy W?
To contact Tracy W send an email to [email protected] or [email protected]. If you want to call Tracy W try calling on +15128005063 and +15128005064. (updated on November 04, 2024)
What is Tracy W net worth?
Tracy W has an estimated net worth of $750,000 to $999,999
What company does Tracy W work for?
Tracy W works for Boston Scientific
What is Tracy W's role at Boston Scientific?
Tracy W is Site Head of Quality, Associate Director, Quality
What industry does Tracy W work in?
Tracy W works in the Medical Equipment Manufacturing industry.
Tracy W Email Addresses
Tracy W Phone Numbers
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