Marlene Mulero-Betances Email & Phone Number

Warsaw, In, Us

Warsaw, In

Project Management support for the Regulatory Transformation team. We are supporting various supply chain transformation initiatives for the Medical Device sector.

Warsaw, In

Define business strategy, oversee quality management system, drive sales and marketing, and manage business operations for provider of packaging / labeling outsourcing solutions for medical device industry.* Secured Investor seed money for startup and developed the FDA and ISO 9002 compliant quality system.* Achieved impeccable quality record and successfully passed every customer audit to date.

Warsaw, In

Provided Project Management and process improvement support for the Product/Quality Hold process. Worked with Quality and Operations to facilitate the timely investigation of Product Holds, facilitated disposition of the impacted inventory, and communicated status to the Supply Chain/Commercial organizations.

Warsaw, In

Served as senior IT executive for 1 of the largest orthopedic device companies in the world. Partnered with Business Analytics, Commercial Sales Operations, and R&D teams to identify and implement technology solutions. Facilitated customer negotiations and patient support offerings.* Team implemented the 1st DePuySynthes Franchise Adhoc sales reporting tool in less than 2 months, providing franchise Account Managers with complete information about customer sales with all DePuySynthes companies, information critical to franchise contract negotiations.* Built strong sense of community as IT Site Leader for DePuySynthes Warsaw Campus by facilitating recurring site management meetings, town halls, team building activities, and on-site training opportunities.

Warsaw, In

Led the Pre-Day-1 IT Program Management Office for $19.7B Synthes acquisition. Co-led development of integrated DePuySynthes IT PMO process. Assumed additional responsibility as Acting IT Site Director and member of Joint Reconstruction Management Board.* Delivered all Day-1 commercial IT requirements on time and within budget, including coordination of all resources, budget management, and development and implementation of pre-integration PMO processes.

Warsaw, In

Direct management of the $15+ million IT Commercial project portfolio for five Operating Companies in the J&J Medical Device and Diagnostics sector. * Leading a diverse team of Project Managers located in different parts of the world. * Key Leader in the implementation of the first J&J IT Project/Program Management Office.

Warsaw In

Led deployment of IT Investment Program Management Office model with clear and repeatable processes to ensure alignment of priorities, compliance with SDLC requirements and transparency of projects status.* Direct management of the $21.4M IT project portfolio for DePuy franchise.* Implemented an outsourced delivery model, increasing number of projects delivered more than 100%.

Warsaw, In

Managed team responsible for all DePuy Orthopaedics quality system documentation, administrative support for Agile Document Management system, and PRMS Item master maintenance.* Managed 2 highly complex departments within organization concurrently; replacement required addition of another manager.

Warsaw, In

Led US-based Label Development Team in design of all DePuy Orthopaedics product labels worldwide.* Brought innovation to poorly performing service, transforming it into organization chosen to lead pilot of DePuy franchise label design and printing application.* Assumed leadership for worldwide harmonization of label design and production printing processes, across DePuy franchise. Received J&J President's Award in recognition of role on team.

Warsaw, In

Developed and implemented internal audit program, including corrective action support, for newly integrated DePuy organization. Served as member of JJPI / DePuy integration team.* Received Standard of Leadership award in recognition for performance as Y2K Product Compliance Lead.

New Bedford, Ma

Supervised the Inspection departments. Participated on and supported new product development teams. Responsible for Knee Instrument Process Validation Protocols, Engineering Reports, Installation Qualifications and process FMEA’s.

Norton, Ma

Performed quality system audits of Supplier sites and Johnson & Johnson Professional facilities around the world. Assessed compliance with the applicable quality system standards and/or regulations (ISO9000, FDA Quality System Regulations, Medical Device Directive, Military Specifications) and J&J Quality and Compliance policies.Provided support for the development of quality systems.Certified as a Quality Auditor by the American Society for Quality.

Rochester, New York Area

Supervisor for Receiving Inspection and Final Inspection. Participated in and supported new product development teams. Responsible for mechanical assembly and supported Printed Circuit Board (PCB) population processes (though-hole and surface mount technologies). * First Quality Engineer hired by the company.* Developed, implemented and maintained quality system documentation for manufacturing, and inspection processes. Achieved ISO 9001:1994 quality system registration.* Developed and implemented a Supplier Dock to Stock program.

Ms, Quality And Regulatory Affairs

Bs, Mechanical Engineering

Activities and Societies: SHPE, SWEI was a Student Supervisor at the Balch dining hall.

High School Diploma, Mechanical Engineering

Activities and Societies: Swim Team, Service Squad, Stage Crew for the Theatre ClubI was a Mechanical Engineering major.