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.
• Project Management –… Show more
• 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..
• 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.
• 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.

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.
• 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.
• 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.
• 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.
• 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.

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.
• 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.
• 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.
• 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.

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.
• 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.
• 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.
• FDA/Notified Body Audit Support - Participated as management representative designee, subject matter expert, and backroom support. Coordinated response communication, planning, implementation, and effectiveness.
• 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