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 regulatory and company objectives.Provide leadership to multi-disciplinary teams and define quality procedures, standards, and controls to ensure compliance with national and international regulations. Possess the capability to build working relationships with internal and external business partners.

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 infrastructure to achieve goals. * Transformed operations through the establishment and implementation of a quality system to effectively mitigate risk and enable the business to support 15% year-over-year growth.* Championed business and regulatory compliance initiatives, achieving all RA requirements for EN ISO 13485:2016 medical devices, achieving zero non-conformance results in the first ever site audit.

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.* Appointed lead of QA design, risk management, and software QA in all Boston Scientific communities; created harmonized businesses processes across multiple divisions, enabling rapid product development while maintaining regulatory compliance.

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 for one quality system.* Managed global management controls and processes and local processes for the executive committee and CEO.* Spearheaded the management and administration of the global corrective and preventive action (CAPA) system, including CAPA execution, Pilgrim integration with the information systems team, and the analytics metrics package.

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 audit readiness assessments to ensure all system and processes were optimized to meet both internal and regulatory guidelines.* Aligned requirements across multiple business units by partnering with key site leaders to standardize systems.* Teamed with corporate stewards to restructure and reengineer the trunk stock program for capital and single use devices.* Delivered key performance metrics and developed presentation for corporate reviews, detailing quality system effectiveness.

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.* Built a 14-member team with six direct reports charged with redesigning quality metric reporting and developing quality reports subsequently becoming standard practice to enhance and communicate corporate-wide performance.* Reengineered Boston Scientific’s management review process by working with site management through the CEO.* Established a global compliance council comprised of quality systems management for all manufacturing sites.

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, leveraging project management best practices.* Deployed a quality metrics system division-wide, contributed to the implementation of a change control system, and restructured a surgical templating overlay creation and approval system to support ongoing performance goals.* Drove performance improvement by revising the marketing literature approval system to reduce throughput time 85%.

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, risk analysis, management review, and CAPA systems.* Transformed the internal audit program to mitigate compliance risk; trained 65 auditors and completed three audits.* Implemented validation requirements across three sites as part of the 21 CFR Part 11 compliance program, including QC labs, HPLCs, spectrophotometers, manufacturing, handling, and document control, reducing throughput time 40%.* Directed initial FDA inspection preparation with no quality system observations raised and facilitated the first-ever, commercial release of bone morphogenic protein’s combination drug device domestically.

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