Morgane Serpa Email & Phone Number

Durham, Nc, Us

Wayne, Pa, Us

Wayne, Pa, Us

Wayne, Pa, Us

Wayne, Pa, Us

• Managed up to 5 Complaint and Adverse Event Specialists, 1 Sr. Quality Engineer, and 1 Quality System Specialist.• Managed the on-boarding and training of European counterparts to the complaints management process in SAP 6.0. • Established multiple process improvements to eliminate waste a reduce processing time of complaints by on average and improve the quality of investigations.• Hosted Corporate and Third Party Audits. Assisted upper management in 2 FDA inspections (domestically and internationally). • Collected, summarized, evaluated and presented data at Quality System Review Board (QSRB) and Management Review meetings.

Wayne, Pa, Us

• Manage FCA activities from the generation of an Event Investigation Form to the execution of the FCA review boards decision, and eventual destruction of material. • Managed CAPA, QSRB, and MRB on the local and BU levels. • Assisted in notified body and third party audits. • Introduced 5S and visual control systems into the Warehouse and Quality lab.• Managed re-labeling project of over 2.5 million products to comply with Medical Device Directives (MDD) including the management of 9 temporary workers. Project was completed ahead of schedule and within budget.

Frisco, Tx, Us

• Assisted in the development and global implementation of key Quality System Processes across the orthopedic division (e.g. Complaint Handling, CAPAs). • Optimized manufacturing processes, introduced flow, and visual controls throughout operations which increased efficiency, reduced lead time, reduced WIP, and improved on-time delivery.• Revised and created Standard Operating Procedures (SOP) and Work Instructions to create standard work for associates.

Frisco, Tx, Us

• Lead root-cause analysis projects for both the 'feedthrough' and 'electrode' area as well as performed FMEA’s to help with the transfer.• Managed 14 associates in the production of over 21 million dollars in revenue.• Troubleshot and corrected numerous problems associated with the production of biocompatible implantable devices.o Quality control and supplier issues (handled most nonconformances, CAPA’s and SCAR’s) o Assisted with assembly and manufacturing defects/failures• Tackled added responsibilities during the facility transfer (e.g. electrode team leader, document control assistant and training coordinator assistant).• Scheduled production and maintained our largest customer’s inventory supply within the preset ranges despite the plant closure and a 50% decrease in the workforce.• Organized and oversaw the outsourcing of all electrode parts during equipment transfers while still maintaining a 95% OTD for customer base.

Madison, Wi, Us

Bachelors Of Science, Industrial Systems Engineering

Education record