Scott Wright Email & Phone Number

Acton, Massachusetts, US

Provide strategic direction and leadership for Insulet Quality Engineering

Boston, MA, US

Incisive quality systems and operations leader with a track record of success leading the design, implementation, and improvement of globally leveraged quality operations systems and frameworks. Background demonstrates 25+ years of success building a culture of quality, compliance, and continuous improvement while driving strategic activities to support.

Washington, D.C., US

Provide leadership, drive improvement, problem solving, and business efficiency to Juul Labs North American manufacturing and distribution operations

Chicago, IL, US

ALLEN MEDICAL (a Division of Hill-Rom Corporation) (2014 – 2019)Director, Quality Assurance (QA) & Regulatory Affairs (RA)Oversee the design, build, and distribution of products worldwide for Allen Medical, a leading $80 million class I medical device manufacturer. Provide strong leadership to a cross-functional team of 18, building a high performing.

Marlborough, MA, US

Senior Manager, Global Quality Systems, Design QA, Risk Management, & Software QA Promoted to oversee global process transformation charged with standardizing all processes across Boston Scientific. * Avoided $650,000 in costs by standardizing the post market surveillance program for the global environment, driving efficient and scalable work processes.*.

Marlborough, MA, US

Served as a key manager for Boston Scientific’s corporate headquarters, holding full accountability for developing and launching quality system management protocols and processes across multiple sites to enhance organizational performance and effectiveness.* Created a global quality manual, deployed to 20+ sites, enabling harmonization and common processes.

Marlborough, MA, US

Oversaw quality systems and compliance functions for Boston Scientific’s Women’s Health division, including management controls, management review, CAPA, design assurance, internal audits, and supplier controls. Managed a team of 12 type of personnel.* Conducted compliant investigations and supplier, internal audits, CAPA, ISO/FDA audit preparation, and.

Marlborough, MA, US

Managed Boston Scientific’s quality systems, providing strategic leadership to optimize performance and maintain compliance.* Deployed a company-wide quality system in accordance with EN ISO/ISO 13485:2003, meeting all time and budget parameters.* Re-architected the corporate quality manual, delivering an interactive, Web-based, and intuitive product.*.

Kalamazoo, MI, US

STRYKER (Jun 2003 – Oct 2004)Project Manager, Quality Systems – Stryker Orthopaedics (2003 – 2004)Selected to oversee the reengineer of the design control process. Mentored and guided three staff in attaining CQA and CQIA ASQ qualification. Served on the 21 CFR Part 11 assessment team.* Led a division-wide design control system reengineering initiative.

Kalamazoo, MI, US

Oversaw the development and implementation of quality systems in adherence to GMPs and QSRs, receiving fast-track career promotions from quality engineer to compliance supervisor within 14 months. Managed document control and compliance, providing leadership to eight direct reports.* Redesigned compliance, product logistics, inspection, design control.

Kalamazoo, MI, US

Senior Quality Engineer, Surgical device Hand tools, Responsible for all things quality, supplier Development, Internal manufacturing processes, and customer interaction

Bachelor Of Science - Bs, Ocean Engineering

Masters Of Business Administration