Mohammad Siddiquee Email & Phone Number

Center Valley, Pennsylvania, Us

• Defining processes and systems to meet quality goals, using KPIs for monitoring, • Managing programs and training records, • Ensuring compliance with FDA regulations and Medical Device Single Audit Program (MDSAP),• Identifying and solving process/system issues, • Utilize systems like Salesforce.com, SAP CRM, SAP ECC, and EtQ Reliance. • Ensuring field service and the Technical Assistance Center (call center) compliance and addressing service record problems. • Responsibilities include recognizing opportunities to enhance process and/or system monitoring, identifying issues, and proposing potential solutions. • The audit programs will function as key performance indicators (KPIs) or management by objectives (MBOs) for evaluating individual performance. • The Quality Analyst plays a significant role in ensuring the organization's service delivery records and processes operate with efficiency, effectiveness, and compliance with quality and regulatory standards. • Additionally, this role entails ensuring that Service Delivery complies with required quality standards, such as the FDA Quality System Regulation and ISO 13485.

Hanover, Maryland , Us

Responsibilities:Assigned to Arthrex, Inc. Performed complaint investigations on a timely basis to meet closure goals and evaluated product complaint documentation for completeness and consistency. Analyzed historical complaints for consistency in evaluation, documentation, and closure. Manages, assembles, and maintains standard closing statements. Performed complaint closures (High volume responsibility reporting directly to internal complaint team for review and approval), Product History Reviews, and OEM non-return closures. Assigned for uniformity in all user-selected descriptions and information on all complaints. Worked with Product Surveillance Specialists to resolve discrepancies in complaint files. Worked with Product Surveillance Specialists on proper methods to document complaint file information Review all product. Worked with various Engineering teams to review and conduct proper complaint investigations.

Edison, Nj, Us

Responsibilities: Assigned to Johnson & Johnson. Prepared and submitted MDR report to the FDA for compliance and contributed to gather information for Health Authority Requests of additional information within the required timelines. Also, supported through collaboration with cross-functional teams for product investigation compliance. Routinely submitted Medical Device Reports (MDRs) for EUMDRs to European countries and APAC countries as required, capturing the essence of reportable events in clear, simple language. As well as experience in EU MDR compliance and reporting daily basis. Experience working with cross-functional product development teams to ensure regulatory compliance. Maintained accuracy in required submission information of regulatory reports and participates in tracking metrics for dept. Prioritizes work according to needs of department to supporting regulatory reporting and complaint investigation timeliness. Demonstrated to respond to the urgent needs of the team, with proven track record of meeting deadline and supported for problem solving/root cause analysis.

Responsibilities:Assigned to Kavo Kerr Group. Supported to the Regulatory, Operations, and Engineering, Quality departments by managing all open complaints and escalating Out of Box failures, suspected Adverse Events to the appropriate teams, and providing routine & ad hoc reports in support of reliability improvement projects and other Post Market Surveillance activities. Reviewed new complaint notifications to ensure that the correct status was assigned and coordinated with Technical Support personnel for any changes that are needed. Managed complaints to ensure that they are closed within 90 days of initiation. Regularly obtained Device History Records as required to support investigations.

Westmont, Il, Us

Responsibilities:Assigned to Draeger Medical, Inc. Provided administrative support to the North American Customs & Export Control department. Maintaining complete and accurate documents supporting international licensed activity. Providing support to process import documentation by using Amber Road UPS FGV and Trade Automation. Verified the completeness of Automated Export System (AES) filling records a documentation.

Westmont, Il, Us

Responsibilities:Assigned to Draeger Medical, Inc. Where prices list, pricing tools or standard pricing exists, issue quotations promptly to assigned customers. Follows up to close all quotes generated verbally/via email at assigned customers to ensure protection and growth of business. Accurate & timely entry of customer orders in SAP in accordance with established processes as well as placing backorders and resolve discrepancies. Process customer returns/paperwork as required.

Wilkes-Barre, Pennsylvania, Us

Responsibilities:Sourced candidates select candidates for free-screen from online job Boards-LinkedIn, online job boards, social media, internet advertisement, and ATS system, etc., reached-out possible eligible candidates, posted jobs on the website, made cold call, conducted phone interviews. Conducted background check, instant drug test, reference check, and I-9 documentations.

Cherry Hill, Nj, Us

Responsibilities:Coordinated recruiting process with various hiring managers. Routinely, conducted phone screening, applicant tracking, background check, and drug test for recruitment process. On boarded new hired, open, and close assignment.

Bachelors Of Science In Technical Management, Accounting

Master Of Business Administration - Mba, Human Resources Development