Quality Systems Specialist
Medtronic
مجموع سنوات الخبرة :11 years, 8 أشهر
▪ Directed the overhaul of training initiatives within the operational unit by engaging with senior management to understand and
address their specific requirements.
▪ Delegated responsibilities and provided comprehensive training to individuals in alignment with ISO, FDA, and company
standards.
▪ Successfully prepared for and provided extensive support during FDA, corporate, and BSI audits, contributing significantly to
the attainment of operating unit certification.
▪ Proactively monitored key performance indicators (KPIs) within the operational unit, compiling and subsequently delivering
comprehensive presentations to key stakeholders
▪ Developed and implemented a robust communication system to address quality and compliance inquiries and issues within
the operating unit.
▪ Led project management efforts for a medium-scale initiative ($1 million >) aimed at enabling the company to achieve legal
authorization for product sales within the Thai market.
▪ Led the establishment of a dedicated manufacturing facility within the organization, overseeing all aspects of its development
and implementation
▪ Assisted with the FDA 21 CFR Part 117 accreditation of the facility by preparing for audit and executing required tasks.
▪ Vigilantly monitored environmental data for any anomalies, promptly determining and implementing appropriate corrective
actions in response to deviations.
▪ Established quotation system for outsourcing department services to customers by studying operation expenses and
competitor quotes.
▪ Standardized training records between Minnesota and Connecticut Medtronic sites, allowing North Haven site to become the
mother site for all Medtronic lab sites.
▪ Designed and executed a study looking at the degradation of endotoxin over time so that delayed shipments of samples from
offsite facilities can be assessed for the validity of the samples’ endotoxin test results.
▪ Conducted comprehensive time analysis for bioburden testing across diverse product lines and generated a detailed report
aimed at enhancing product-to-technician allocation. This initiative led to a 20% augmentation in daily bioburden testing
capacity.
Trained new employees while maintaining daily responsibilities in high paced environment.
Managed high volumes of phone calls with prescribers, patients, and insurance companies, resolving issues and building customer loyalty.
Maintained and ordered pharmaceutical stock. Reduced product waste by 14%.
Learned and applied HIPAA standards