Brian Fredrickson Email & Phone Number

Largo, Florida, United States

• Quality Leadership – Part of the leadership team responsible for oversight of a $370M Orthopedic portfolio and a rejuvenation of the new product development process. Participate in regular project and business reviews as well as strategic planning. Initiated a program to improve oversight and communication of sustaining engineering activities, priorities, and the cross functional support resources required which has evolved into a corporate best practice. • Project Management –… Show more • Quality Leadership – Part of the leadership team responsible for oversight of a $370M Orthopedic portfolio and a rejuvenation of the new product development process. Participate in regular project and business reviews as well as strategic planning. Initiated a program to improve oversight and communication of sustaining engineering activities, priorities, and the cross functional support resources required which has evolved into a corporate best practice. • Project Management – Lead various corporate level projects involving global team members. Sterilization redundancy project was successful in protecting the corporate sterile product supply chain of approximately $700M. Core member of the EU MDR steering committee coordinating activities to ensure compliance of the QMS as well as updating technical documentation to maintain product in the European market. • Regulatory Compliance – Deputy Management Representative for the Largo Facility. Host for certification audits (MDSAP, ISO13485) as well as subject matter expert for Design Controls and Risk Management for all external audits.• Site Leader, Quality Assurance (interim Sep 2018-May 2019) – Provided leadership of the Quality Organization supporting both Largo Manufacturing Operations and Orthopedic New Product Development with a staff of 35 engineers and managers. Responsible for nonconformance management, CAPA, and management review meetings. Collaborated with leadership to establish site direction and goals, establish supporting processes, and report status. Show less

Largo, Florida, United States

• New Product Development – Manage a team of quality engineers to support the CONMED Orthopedics New Product Development pipeline including oversight of day-to-day activities, mentoring, and performance management. Work with divisional leadership to drive cultural change within the cross functional development teams. Provide quality leadership throughout the division supporting NPD, Regulatory, International, Manufacturing, and Commercial teams. Lead teams to improve customer experience… Show more • New Product Development – Manage a team of quality engineers to support the CONMED Orthopedics New Product Development pipeline including oversight of day-to-day activities, mentoring, and performance management. Work with divisional leadership to drive cultural change within the cross functional development teams. Provide quality leadership throughout the division supporting NPD, Regulatory, International, Manufacturing, and Commercial teams. Lead teams to improve customer experience through reduction of defects (root cause investigation and CAPA) or performance improvements (feedback).• Design Assurance/Risk Management – Responsible for oversight, update, and implementation of the Corporate Design Control and Risk Management systems in conjunction with R&D. Includes developing processes, establishing procedures, and conducting training across the corporation.• Merger and Acquisition – Participated in diligence activities for merger and acquisition activities including on-site exploratory visits, due diligence reviews, and integration into CONMED. Worked with cross functional team to develop a new M&A diligence process based on experience and lessons learned.• Resource Management/Budget - Deploy resources to meet company needs in support of NPD, design changes, compliance, and other company projects. Interface with management to plan for company resource needs. Responsible for departmental budget planning, monitoring, and resolution of any discrepancies. Show less

Largo, Florida, United States

• New Product Development – Core member of development teams, both local and remote, for bringing new products to the market. Responsible for quality planning, oversight of design validation & verification activities including statistical analysis of data, development of risk management documents, coordination with manufacturing in developing and validating new processes, and assist Regulatory Affairs for 510(k) submissions and technical files. Implemented new practices to reduce development… Show more • New Product Development – Core member of development teams, both local and remote, for bringing new products to the market. Responsible for quality planning, oversight of design validation & verification activities including statistical analysis of data, development of risk management documents, coordination with manufacturing in developing and validating new processes, and assist Regulatory Affairs for 510(k) submissions and technical files. Implemented new practices to reduce development time while meeting testing and documentation requirements. Led multi-site, Quality Assurance teams (Supplier Quality, Sustaining Quality, Receiving Inspection, and Complaint/MDR) for their input into the development process. • Post Market Surveillance – Developed process for post market surveillance of new products consisting of complaints, sales, adverse events, and manufacturing nonconformances. Responsible for investigation of new product issues including determination of root cause, risk assessment, containment, and recommendation of corrective action.• Factory Floor Support – Cradle to grave Quality support for various processes/product lines including plastic injection molding as well as titanium, peek, and bioabsorbable implants. Addressed nonconformances, monitored and qualified processes, and investigated complaints. Show less

Largo, Florida, United States

• Responsible to review the company’s global quality systems for compliance to regulatory standards including FDA QSRs, ISO 13485, MDD, and CMDR. Managed various key QMS processes including CAPA, Internal Audits, Recalls, and Management Review.• Warning Letter Remediation – Led teams to reestablish QMS processes in response to FDA Warning Letter. Authored new processes for CAPA, Internal Audits, and Management Review which received compliments during FDA close out… Show more • Responsible to review the company’s global quality systems for compliance to regulatory standards including FDA QSRs, ISO 13485, MDD, and CMDR. Managed various key QMS processes including CAPA, Internal Audits, Recalls, and Management Review.• Warning Letter Remediation – Led teams to reestablish QMS processes in response to FDA Warning Letter. Authored new processes for CAPA, Internal Audits, and Management Review which received compliments during FDA close out audit.• FDA/Notified Body Audit Support - Participated as management representative designee, subject matter expert, and backroom support. Coordinated response communication, planning, implementation, and effectiveness verification.• Corporate Auditor – Corporate lead auditor for assessment of global quality management system (QMS). Show less

Largo, Florida, United States

• Responsible for daily support of manufacturing activities, resolving production issues in a timely manner.• Primary member of Process Assurance Steering Committee; training employees for preparation and execution of process validation activities, approval of completed protocols and maintenance of process assurance procedures.• Process development and improvement using tools of lean manufacturing (kaizen) and six-sigma.

Bs, Chemical Engineering

Activities and Societies: Orientation Counselor, Computing Services, Scotch-n-Soda

Ms, Engineering Management, Engineering/Industrial Management