Brett Forstrom Email & Phone Number

Newtown, Ct, Us

Marlborough, Ma, Us

- Leads a team of 15 quality professionals ranging from Inspector through Quality Engineer, to oversee manufacturing of X-Ray medical equipment. Supports >10 product lines for new equipment, and numerous device refurbishment processes.- Ensures that regulatory compliance is maintained for Quality and Manufacturing procedures; per FDA, ISO, UL, EU MDR, and INMETRO requirements. Serves as a subject matter expert during audits performed by regulatory and notified bodies.- Accountable for timely release and shipment of medical equipment. Prioritizes final inspections, receiving inspections, first article inspections, rework inspections, and nonconformance investigations to align with dynamic business requirements.- Provides strategic Quality leadership for a wide range of business objectives such as: product line transfer, site transfer, part transfer, part qualification, process validation, product rework, MRB reconciliation, and continuous improvement.- Facilitates management of all nonconforming material; includes documentation, segregation, investigation, and disposition.- Serves as SME during development & validation of processes used for disinfection and requalification of X-Ray equipment.- Collaborates with Quality Engineers to resolve investigations, analyze process capabilities (Cpk) & access risk (pFMEA).- Develops and authors Quality Plan Records in support of manufacturing site transfer and production line transfer projects.- Consulted during Kaizen events in multiple functional areas, which are intended to reduce waste and improve efficiency.- Supports inspection and release of new medical equipment from R&D to registered clinical sites.- Certified auditor for EU MDR; European Medical Device Regulation 2017/745.

Danbury, Ct, Us

- Responsible for meeting/exceeding goals related to laboratory turn-around-time; includes Drug Product Release Testing, Instrument Qualification, Method Validation, resolving Laboratory Investigations, and implementing CAPA decisions.- Managed the workload and schedules of multiple direct reports, mentors the advancement of individuals within the group.- Served as a subject matter expert during audits & inspections of Quality Systems; FDA, ISO, and business partners.- Performed Risk Assessments, interpreted regulatory guidelines, and performed CRO monitoring of defined KPIs.

Danbury, Ct, Us

- Performed operation, maintenance, and troubleshooting of HPLC, GC, IC systems; utilizes Empower 3, ChemStation, & Chromeleon software to acquire and process chromatography results (Alliance, Agilent, Dionex) - Validated test methods used for quantitative determination of E. coli host cell proteins in Insulin (ELISA)- Performed Extractable & Leachable Testing; included Controlled, and Microwave Assisted Extraction (Anton Paar)

Danbury, Ct, Us

- Conducted release testing of raw materials following USP/EP monographs and proprietary methods. - Developed & validated cleaning verification methods for pharmaceutical equipment (TOC analysis, Sievers 900)- Performed Microbiological analysis of API and finished product samples; microbial limits and bioburden testing

Storrs, Ct, Us

- Purified large quantities of recombinantly expressed protein from E. coli - Characterized target proteins by biological activity in tissue culture, SDS-PAGE, Lowry Assay, silver staining, and immunoblotting- Propagated and maintained human breast cancer cells in tissue culture (MDA-MD-231)- Extracted DNA from plant/animal tissues, amplified DNA by PCR, and performed 32P Southern blot hybridization

Bachelor Of Science, Molecular Biology

Molecular Biology