- Name: Ziaur Rahman
- Email: firstname.lastname@example.org
- Phone Number: 3522227560
- Location: Florida, USA
- Standards: ISO13485:2016, ISO9001:2015, MDSAP, MDD, MDR
A highly accomplished professional with 10+ years of experience in Medical Device manufacturing & healthcare industries, over two years of experience in the RF communication sector. Expertise in Auditing of Active Medical Device Manufacturing, Strategic Sourcing, Supplier Consolidation, Supplier Financial Risk Assessment, Supplier Capability Assessment & Qualification, Supplier Audit, Quality System Audit, Quality System Remediation, RoHS & REACH, Quality Engineering Methodologies, Process Validation, Equipment Validation, Design Verification, Non-conformance Management, Supplier Process Control, Supplier Relation, and FDA compliance. Outstanding team builder in supporting quality system, risk management, root cause analysis, reliability assessment, and compliance with the various notified body.
Specialties: Certified Lead Auditor-(ISO13485:2016, ISO9001:2015, MDSAP, MDD, MDR), ASQ Certified CQE, specialized in Auditing of Active Medical Device Manufacturing, MDD, MDR, MDSAP, 21 CFR part 11, 21CFR part 820, ISO 9001:2015, ISO 13485, IEC 62304, IEC 60601, ISO 14971, Risk Analysis, FDA regulation, Product Localization, (DQ/IQ/OQ/PQ/PPQ) protocols and reports, FMEA, DFMEA, DOE, Reliability Assessment, FTA, CAPA, Internal Audit, Process Validation, Automated Computer System Validation (CSV), Agile, SAP, SQL, MS Access, Lean Methodologies, Six Sigma, C++, Reliasoft., Product Sourcing, International Purchasing, Govt Bidding and Tender Execution.
To the novice quality manager, ISO jargon can be extremely overwhelming. What is an NCR? What do you mean by OFI? Are we certified or accredited? But before you go and pull out your hair, let’s take a moment to go over some of the most frequently used terms and their definitions with regards to ISO and Management System Certification.