Ashwini Mane Email & Phone Number

Toronto, Ontario, CA

Lake Forest, California, US

Geneva, Switzerland, CH

Richardson, Texas, US

• Worked on FDA inspection data from 2008-2018 to study the pattern of non-conformances in the QMS.
• With the help of Minitab performed statistical analysis on the acquired data.
• Performed test for normality, t-tests, ANOVA, variance tests, hypothesis tests, test for correlation/regression and plotted various graphs to analyze the spread of collected data.
• Used the information gathered and with the help of Pareto charts collected the most vulnerable processes to create an audit checklist to avoid future non-conformances in the QMS.

Lake Bluff, IL, US

• Worked on portable and standalone ultrasound systems of multiple manufacturers: Phillips, Siemens, GE, Mindray, Sonosite, Esaote, Zonare. Provided service support to customers all over the US.
• Addressed different challenges presented by various systems and their peripherals, perform software testing, software reloads, evaluated probes to check for crystal damage and repaired almost 50 back-end processors.
• Reviewed, identified and remediated CAPAs for proper content (containment, problem investigation, risk assessment, GDP, root cause, action plans, etc).
• Evaluated and prioritized all product complaint reports received from our affiliates.
• Conducted periodic assessment of complaint & CAPA files.

Richardson, Texas, US

• Built a complete QMS document for a class III high-risk device by performing a gap analysis to comply with 21 CFR 820 and ISO 13485.
• Created quality policy, drafted SOPs, process flowcharts, input/output diagrams, workflow maps, and forms in accordance with regulations.
• Audited identification, traceability, nonconforming product, acceptance status, production and process control subsystems of ISO 13485 and provided support to integrate and consolidate all documents into a quality.

Richardson, Texas, US

• Gained deep understanding of ISO 13485, ISO 14971 (Risk Management) and 21 CFR 803 (MDR), 807 (Medical device listing and 510(k)), 812 (IDE), 814 (PMA), 820 (QSR).
• Developed a strong understanding of standard regulatory pathways such as 510k, PMA, IDE, De Novo, HDE, etc., their requirements, and critical risk factors that inform Biomedical Design.
• Worked as a team member to create, present and defend a unique regulatory pathway for a class II medical device to gain market entry in the USA (FDA), EU (MDD), and Russian (RZN) market.
• Analyzed the quality subsystems and acceptance activities, to perform the Health Hazard Evaluation for a medical device recalled from the market.

• Handled customer complaints, identified failure by root cause analysis, implemented corrective and preventive actions.
• Worked with cross-functional teams to provide guidance on the maintenance of existing products to prove compliance with the latest standards of cleaning and sterilization of medical devices.
• Continually work with internal resources such as sales representatives, marketing and external resources such as customers, and physicians to complete the complaint file and investigation.
• Led CAPAs, NCRs, and internal audits and investigations.
• Determined reportability of complaints pertaining to MDR submission. Generated monthly complaint metrics for Quality Management Review.
• Worked on customer complaints/ Post market surveillance reporting (MDR).

Operated and trained the doctors on multiple medical devices like x-ray, monitor, ventilator, ECG, ESU, syringe pump, and anesthesia machines. Initiated and persuaded sales of the product by technical marketing and demonstration.

Master Of Science - Ms, Bioengineering And Biomedical Engineering

Bachelor Of Engineering - Be, Biomedical/Medical Engineering