Quality Analyst
Resume:
Mohammad Ali Siddiquee
Lansdale, PA 19446
Cell: 267-***-****
Email: ************@*****.***
LinkedIn: https://www.linkedin.com/in/alisiddiquee
Summary:
Results-driven self-starting Medical Device professional with proven success in post-market regulatory compliance, complaint coordination, complaint investigation & closures, Quality Analyst, support service management, and account management. Motivated to utilize 5 years of expertise in the medical device industry to achieve organizational goals with high productivity. Skilled in general orthopedic instruments and routinely contributes to submitting medical device reports (MDR) to the FDA.
Professional Experience:
Millenium Software, Inc- Olympus America, Inc. August 2023 – Present
Quality Analyst
Using Pivot tables, VLOOKUP’s, etc. in Excel. SAP, Salesforce, or Reliance EtQ
Reviewing complaints in SAP/Salesforce/EtQ platform
Auditing medical device complaints by reviewing intake and estimation codes notes on non-conformance based on procedures.
Identifying what needs to be corrected in the complaint file and executing rework of the complaint file and close the complaint after updating.
Regulatory Complaints Investigation Specialist
Actalent Services, Inc (Assigned to Arthrex, Inc.-Remote)
Jul 2022 - Jan 2023
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.
Managed, assembled, and maintained standard closing statements.
Conducted complaint closures, Product History Reviews, and OEM non-return closures.
Ensured uniformity in all user-selected descriptions and information on all complaints.
Worked with Product Surveillance Specialists to resolve discrepancies in complaint files.
Collaborated with various Engineering teams to review and conduct proper complaint investigations.
Regulatory Health Authority Reporting Specialist
Pioneer Data Systems (Assigned to Johnson & Johnson, West Chester, PA)
Aug 2019 - Jan 2022
Prepared and submitted MDR reports to the FDA for compliance and gathered information for Health Authority Requests within required timelines.
Collaborated with cross-functional teams for product investigation compliance.
Submitted Medical Device Reports (MDRs) for EUMDRs to European and APAC countries as required.
Ensured compliance with EU MDR and reporting on a daily basis.
Worked with cross-functional product development teams to ensure regulatory compliance.
Maintained accuracy in required submission information of regulatory reports and tracked department metrics.
Prioritized work to support regulatory reporting and complaint investigation timeliness.
Responded to urgent team needs, meeting deadlines, and supported problem-solving/root cause analysis.
Assisted to organize internal and external audit preparedness.
Proactively participated in the team activities to make effective contribution.
Complaints Coordinator (Contract)
Kelly Services (Assigned to Kavo Kerr Group, Hatfield, PA)
Jun 2018 - May 2019
Supported Regulatory, Operations, Engineering, and Quality departments by managing all open complaints.
Escalated Out of Box failures and suspected Adverse Events to the appropriate teams.
Provided routine and ad hoc reports to support reliability improvement projects and Post Market Surveillance activities.
Reviewed new complaint notifications and coordinated with Technical Support personnel for necessary changes.
Ensured complaints were closed within 90 days of initiation.
Obtained Device History Records as required to support investigations.
Trade Compliance Analyst
Johnson Service Group (Assigned to Draeger Medical Inc., Telford, PA)
Dec 2017 - Jun 2018
Provided administrative support to the North American Customs & Export Control department.
Maintained complete and accurate documents supporting international licensed activity.
Assisted in processing import documentation using Amber Road UPS FGV and Trade Automation.
Verified the completeness of Automated Export System (AES) filing records and documentation.
Support Specialist
Johnson Service Group (Assigned to Draeger Medical Inc., Telford, PA)
Feb 2017 - Jun 2017
Issued quotations promptly to assigned customers using available price lists and pricing tools.
Followed up to close all quotes generated verbally or via email.
Ensured accurate and timely entry of customer orders in SAP.
Handled backorders and resolved discrepancies.
Processed customer returns and related paperwork as required.
Staffing Coordinator/Recruiter
OneSource HR Solutions, Lansdale, PA
Dec 2015 - Apr 2016
Sourced candidates from online job boards, social media, and other platforms.
Conducted phone interviews and pre-screening of candidates.
Posted job openings and made cold calls.
Conducted background checks, drug tests, reference checks, and I-9 documentations.
Recruiter/Staffing Coordinator (Temp)
Accu Staffing Services, Harleysville, PA
Feb 2013 - Nov 2014
Coordinated recruiting processes with hiring managers.
Conducted phone screenings, applicant tracking, background checks, and drug tests.
Managed onboarding, as well as open and close assignments.
Conducted new employee training courses on SOP’s and GMP’s.
Skills:
Microsoft Office
SAP
Sales Force
CRM (Integrated with TrackWise)
Veeva Vault (Basic)
Post-market Regulatory Compliance Reporting
Cross-functional Team Effort
Complaint Investigation
Complaint Audit
Customer Support
Root Cause Analysis
Share Point
Nexus World
My HR
Adobe Acrobat Pro
Technical Writer
Publication
Proofreading
Education:
MBA, Human Resources - Keller Graduate School of Management, Philadelphia, PA - 2015
Bachelor of Science in Technical Management - DeVry University, Philadelphia, PA - 2012
Associate in Business Administration - Lansdale School of Business, North Wales, PA - 2010
Status: US Citizen
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