Mandy Bates Email & Phone Number

Atlanta, Ga, Us

Northfield, Il, Us

St. Paul, Mn, Us

Create and revise work instructions for design controls and engineering change control processes. Create and manage design history files for new product introduction and existing design files. Owner and front room leader for design controls and change control for notified body and internal audits. • Serves as design quality engineer for new product introductions.• Serves as ECO administrator and organizes ECO board meetings for intermediate and high-risk changes.• Collect and analyze metrics for change control process.• Perform CAPA, NC, Complaint investigations for design controls.

Düsseldorf, De

Write and execute design verifications, validations, test methods, control plans, and other related documentation for design process transfers. Create and maintain design history files to support design side activities. Perform capability studies to evaluate processes and equipment. Execute Type 1 and GR&R for fixtures and create associated test methods.

Atlanta, Ga, Us

Created and managed new validation program. Prepared and executed IQ, OQ, and PQ qualifications for production equipment and process methods. Collected and analyzed data for validations and other projects such as First Article Evaluation, and process monitoring. As a member of the engineering team, duties included, executing validations, system documentation, supporting process transfers, FMEA, Control Plans, Quality Plans, and working with clients to ensure validations met operational demands. Perform internal CAPA review and implement corrective and preventive actions. Assisted with internal audit program and perform external supplier audits. Performed process and equipment transfer and start up validations in Hong Kong.• Completed new process and equipment validations in Hong Kong to increase total production in addition to US supply. • Created a new master validation plan program to issue validation numbers, track completion, and track off site storage. This critical tool for audits is used to track validations for each product and customer.

Kennesaw, Ga, Us

Responsible for writing, executing, and analyzing equipment qualifications and sterilization validations. As a member of the engineering team, duties included, executing validations to support products requiring sterilization, working with clients to ensure validations met operational demands and performed routine equipment calibrations. Performed data entry into CalMan database to document equipment calibration.Completed steam sterilization validations, depyrogenation oven validations, and gamma-irradiation sterilization dose audits on or prior to the annual requalification due date.Improved steam sterilization and depyrogenation validation protocols. Revised acceptance criteria to include additional testing to comply with ISO standards and PDA Technical Reports.Revised sterilization protocols and improved data analysis reporting. Created data tables to summarize acceptance criteria thus improving readability. Improved organization of data analysis and reduced the time required to review summary reports by 25%.Served as Kaye software administrator for a staff of ten engineers. Maintained staff access and user classifications for Kaye Validator 2000 (Versions 2.33 & 3.10) and Kaye ValProbes 3.1.Revised and created new material specifications (SOPs) for materials used to execute validations. Reviewed and revised calibration and quality documentation for functionality and compliance.Executed various studies to resolve issues and support current or upcoming validations, such as decreasing the cycle time for an oven while maintaining compliance requirements for depyrogenation.

Kennesaw, Ga, Us

Coordinated and implemented departmental studies and projects. Wrote study protocols, executed testing, collected data, performed analysis, and reported findings. Reviewed validation protocols and coordinated execution with Operations and Engineering departments. Coordinated new device transfers from R&D to Operations.Successfully transferred the ProPatch* Soft Tissue Repair Matrix medical device from R&D to Operations, which received 510(k) clearance from the FDA. Wrote new operating and training procedures, ordered equipment and materials, and trained staff to produce the device. Executed multiple validations for device processing and solution batching.Established a program to execute and track departmental studies that evaluated new materials, equipment, process failures and potential process improvements. Executed over 20 individual studies for the departmental program.Created a management tool to monitor microbiological testing from routine clean room air, surface, and water samples. Monthly trending was performed and reported to management. Increased visibility and ability to act quickly when results were trending out of specification. Designed management tool to evaluate solution-batching processes to identify and evaluate inconsistencies in batching or analytical testing resulting in a 20% reduction in failures after monitoring was initiated.Completed auditor training program and received certificate as a Certified Quality Auditor (ASQ). Performed two external audits and multiple internal audits.

Kennesaw, Ga, Us

Managed the daily scheduling and provided overall work direction to approximately 10 employees. Performed employee performance reviews, interviews, and assisted management with selection and hiring of new employees. Performed manufacturing review of device charts and processing documentation required for product release.Created Access database management tool for process data analysis. Provided analysis of incoming material quality in relation to final product yield, individual technician performance that was used for annual evaluations, and evaluation of anomalies that impacted product yield.Collaborated with procurement vendors to improve the quality of incoming tissue, which resulted in a 25% reduction in processing time. Collaborated with procurement vendors to reduce incoming bioburden on tissue. A series of washes were implemented which reduced the bioburden by 30%. This improvement reduced the chance of LAL failure after the device was irradiated. Assisted with the transfer of two new devices from R&D to Operations. Both devices received CE mark approval for distribution.

Kennesaw, Ga, Us

Responsible for dissection and low pressure fixation of porcine heart valves. Assembled, inspected, and sterilized porcine aortic and porcine pulmonary heart valves. Responsible for aseptic preparation and sterile filtration of processing solutions. Performed cryopreservation and packaging of tissues shipped for gamma-irradiation sterilization.

Masters Of Science Quality Assurance, Industrial Engineering

Bachelor Of Science, Biology

Education record