Caroline Byrd Email & Phone Number

White Bear Lake, Mn, Us

Leading Nextern's Quality Assurance and Quality Systems organization, and deploying regulatory and clinical evidence strategies and processes to enable customers to achieve their goals to improve patient lives.

Nussloch, De

Developed program to transition IVD products from IVDD to IVDR for CE Marked products. Managed international regulatory team for global product registrations and implement requirements for trade compliance with legal and supply chain.

Abbott Park, Illinois, Us

Initiated and led Abbott's global initiative to scope and implement Quality System and Business process changes to enable compliance with the European Medical Device Regulation changes that were entered into force May 2017 and apply to industry in May 2020.Directed a team of ~80 engineers and scientists that support all SJM research, product development, and sustaining engineering activities for all SJM’s therapy areas, including pediatrics, Arrhythmia Management, and Structural Heart. Department service expertise includes prototyping services, CAD/Drafting, Materials Sciences, Analytical Chemistry, Biocompatibility, Anatomical Modeling, and Preclinical studies.Managed budget in excess of $12M in annual spend.Collaborated with physicians on new product development, research proposals, publication strategies, and business development opportunities.

Minnetonka, Mn, Us

Responsible for Quality System development and continuous improvement, product development, risk management, supplier assurance, manufacturing quality, product distribution, and post-market surveillance activities.

St. Paul, Minnesota, Us

Managing Quality Engineers and technicians responsible for QA activities for process development, new product launch, and current production processes and products.Sustaining engineering support including Risk Management activities, Project Management of process and product improvement initiatives, CAPA coordination, NCMR management.

Plymouth, Mn, Us

Vevey, Ch

Sr. Quality Engineer tasked with developing, improving, and maintaining Nestle Healthcare Nutirition's Medical Device business's quality system and products (feeding tubes, pumps, and administration sets).• Drafted, managed, and completed a project to create, implement, and train an ISO 13485-compliant medical device quality system separate from the food business’s ISO 9001-compliant quality system.• Managed regulatory-driven, product improvement and cost reduction projects and CAPAs from inception through implementation across five manufacturing and service suppliers.• Updated Risk Management Files for feeding tubes and pumps in accordance with EN ISO 14971:2007.• Completed Essentials Requirements checklist for feeding tubes.• Participated in the BSI audit of the Quality Management System and product Technical Files.

Marlborough, Ma, Us

Core team member of Project Horizon Risk Management team, which is tasked with deploying a lean system to manage product safety risks for the Corporation congruent with EN ISO 14971:2007.• Acted as a sub-team project manager and core team member for development of a Corporate Risk Management System that complies with EN ISO 14971:2007.• Created and actively managed the project’s Organizational Change Management Plan.• Managed a stakeholder analysis identifying who in the Corporation has what stake in the project.• Planned, created, reviewed, presented and managed communications for the team, including communications to Executive Management overseeing the project and the Corporation as a whole.• Managed assigned project risks per the Project Risk Plan.• Managed a sub-team tasked with modeling and piloting Risk Management Project deliverables.• Created, issued, and collated results of a readiness survey given to stakeholders involved with Risk Management System pilots in order to assess teams’ preparedness for change.• Key contributor to the program’s work breakdown structure, schedule, and implementation strategy.• Participated cross-functionally in identifying, resolving, and communicating Risk Management technical issues, including Legacy Guidance and Quality and Business System Linkages with Design Controls, CAPA, Complaints, the Product Development Process and more.• Managed a workstream that defined management’s role in the system and developed tools and metrics to assist management in making risk-based decisions.• Developed Business Process and Software System Requirements that were used to select and validate a COTS relational database software solution (Relex) for managing the Corporation’s product risk assessment and control analyses.

Marlborough, Ma, Us

Core team member of several quality system improvement efforts January 2005 to June 2006 including the launch of a Equipment & Automated Systems development lifecycle and harmonizing process validation policies between international sites.Manufacturing Core Team Member for the cross-divisional Gateway Monorail PDP, a PTA catheter for BSC’s Neurovascular division. Manufacturing engineering team member for the dual-site manufactured Apex POBA catheter PDP.Completed 6-sigma Green Belt training, managed all aspects of a product lifecycle from development and risk analysis through validation and scale-up/launch, managed process and quality improvement projects with capital budgets up to up to $1.4M.

Oversaw the bidding, purchasing, and installation planning of a chromate conversion line for aluminum components.Developed a Kanban material handling system and designed the carts needed for the manufacturing cells.Led a Kaizen event to determine the layout of the machinery in the plant.Developed a new chemical procurement procedure for the Champlin facility.

Saint Louis, Us