Melody Nader
Specialist of Document Control at StatLab Medical Products- Claim this Profile
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Bio
Bob Steagall
Melody is a very hard-working and committed Quality professional. She is a team player who takes her regulatory responsibilities very seriously, but is always a consummate professional and great fun to work with. She’s not afraid to ask questions, and is always available to provide help to others. Melody and I worked together for a year and a half at Intrinsic Medical Imaging, and during that time she guided and developed our Internal Quality System, formulating policies and procedures, creating and presenting training, and preparing the company for eventual interaction with the FDA. I think she did an excellent job, and I recommend her for any position related to medical device Quality System or regulatory work.
Arlene Robbins
I highly recommend Melody Nader for any quality systems position. She is knowledgeable about SOP research and writing. She is extremely proactive about providing all of the SOPs needed for our small, start-up company. She is constantly thinking about the needs, both internally through training, and externally (customer interaction and FDA), that our company will have as it enters the marketplace. Specifically, she has completed SOPs for ISO 13485 for medical devices and FDA 21 CFR Part 820 Standard Operating Procedures creation, controlled release, inspections, report, review, and follow-up. Melody has implemented internal company-wide training of ISO 13485 and FDA 21 CFR Part 820 Standard Operating Procedures, Quality Manual and Good Documentation Practices. She has created and provided instructional training, and created and maintained the master training matrix for employee training.
Bob Steagall
Melody is a very hard-working and committed Quality professional. She is a team player who takes her regulatory responsibilities very seriously, but is always a consummate professional and great fun to work with. She’s not afraid to ask questions, and is always available to provide help to others. Melody and I worked together for a year and a half at Intrinsic Medical Imaging, and during that time she guided and developed our Internal Quality System, formulating policies and procedures, creating and presenting training, and preparing the company for eventual interaction with the FDA. I think she did an excellent job, and I recommend her for any position related to medical device Quality System or regulatory work.
Arlene Robbins
I highly recommend Melody Nader for any quality systems position. She is knowledgeable about SOP research and writing. She is extremely proactive about providing all of the SOPs needed for our small, start-up company. She is constantly thinking about the needs, both internally through training, and externally (customer interaction and FDA), that our company will have as it enters the marketplace. Specifically, she has completed SOPs for ISO 13485 for medical devices and FDA 21 CFR Part 820 Standard Operating Procedures creation, controlled release, inspections, report, review, and follow-up. Melody has implemented internal company-wide training of ISO 13485 and FDA 21 CFR Part 820 Standard Operating Procedures, Quality Manual and Good Documentation Practices. She has created and provided instructional training, and created and maintained the master training matrix for employee training.
Bob Steagall
Melody is a very hard-working and committed Quality professional. She is a team player who takes her regulatory responsibilities very seriously, but is always a consummate professional and great fun to work with. She’s not afraid to ask questions, and is always available to provide help to others. Melody and I worked together for a year and a half at Intrinsic Medical Imaging, and during that time she guided and developed our Internal Quality System, formulating policies and procedures, creating and presenting training, and preparing the company for eventual interaction with the FDA. I think she did an excellent job, and I recommend her for any position related to medical device Quality System or regulatory work.
Arlene Robbins
I highly recommend Melody Nader for any quality systems position. She is knowledgeable about SOP research and writing. She is extremely proactive about providing all of the SOPs needed for our small, start-up company. She is constantly thinking about the needs, both internally through training, and externally (customer interaction and FDA), that our company will have as it enters the marketplace. Specifically, she has completed SOPs for ISO 13485 for medical devices and FDA 21 CFR Part 820 Standard Operating Procedures creation, controlled release, inspections, report, review, and follow-up. Melody has implemented internal company-wide training of ISO 13485 and FDA 21 CFR Part 820 Standard Operating Procedures, Quality Manual and Good Documentation Practices. She has created and provided instructional training, and created and maintained the master training matrix for employee training.
Bob Steagall
Melody is a very hard-working and committed Quality professional. She is a team player who takes her regulatory responsibilities very seriously, but is always a consummate professional and great fun to work with. She’s not afraid to ask questions, and is always available to provide help to others. Melody and I worked together for a year and a half at Intrinsic Medical Imaging, and during that time she guided and developed our Internal Quality System, formulating policies and procedures, creating and presenting training, and preparing the company for eventual interaction with the FDA. I think she did an excellent job, and I recommend her for any position related to medical device Quality System or regulatory work.
Arlene Robbins
I highly recommend Melody Nader for any quality systems position. She is knowledgeable about SOP research and writing. She is extremely proactive about providing all of the SOPs needed for our small, start-up company. She is constantly thinking about the needs, both internally through training, and externally (customer interaction and FDA), that our company will have as it enters the marketplace. Specifically, she has completed SOPs for ISO 13485 for medical devices and FDA 21 CFR Part 820 Standard Operating Procedures creation, controlled release, inspections, report, review, and follow-up. Melody has implemented internal company-wide training of ISO 13485 and FDA 21 CFR Part 820 Standard Operating Procedures, Quality Manual and Good Documentation Practices. She has created and provided instructional training, and created and maintained the master training matrix for employee training.
Experience
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StatLab
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United States
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Medical Equipment Manufacturing
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100 - 200 Employee
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Specialist of Document Control
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Jul 2014 - Present
Report to Director of Quality and Regulatory Affairs of StatLab Medical Products overseeing all tasks associated with the generation, review, processing, updating, controlling, and archiving of all corporate documentation associated with StatLab Medical Products development and manufacturing processes. Implementation of Quality Management System and Document Control in adherence to FDA, ISO 13485, and cGMP. Key member of ISO 13485 certification coordination team, Organizer/Implementer receiving recommendation for ISO 13485 Certification within 11 months of start date. Key member of StatLab Internal Audit Team and present StatLab records during audit visits by company suppliers. Key contact person and facilitator of implementation of the Hazard Communication Standard (HCS) (29 CFR 1910.1200(g)), revised in 2012, requiring that chemical manufacturers, distributors, or importer provide Safety Data Sheets (SDSs) (formerly Material Safety Data Sheets or MSDSs) for each hazardous chemical to downstream users to communicate information on these hazards and including the improved quality and consistency in the classification and labeling of all chemicals and chemical products produced by StatLab. Responsible for product label content, creation, own/operate Label Review Team meetings and final approval of Global Harmonized System (GHS) compliant product labels. Key Member of Product Launch Team communicating on-going with Product Development through evolution to Manufacturing Release and all entities involved to document the finalized new product.
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Retired Document Specialist
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Jun 2020 - Jun 2020
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Retired Document Specialist
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Jun 2020 - Jun 2020
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United Copper Industries
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Denton, TX • contract position
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Quality Management System and Document Control Specialist
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Oct 2013 - Jul 2014
Reported to the Director of Quality of United Copper Industries responsible for implementing Quality Management System and overseeing the implementation and management of Document Control. • Responsible for administering the company’s quality policies and controlled documents in accordance with customer and company requirements including authoring and training of - Document Structure and Item Number Definition SOP, train - Document Controls SOP including defining and rolling out of change control process, train - SOP Creation, train - Corrective and Preventive Action SOP and Form, train - Nonconforming Product SOP and Form, train - Complaint SOP - Customer Communication SOP - External Standards SOP, acquiring and filing of all standards in Document Control, train - Personnel SOP - Quality Records and Record Retention SOP - Device Master Record Control - Internal Quality Audit SOP • Management Responsibilities SOP - Familiarized executive management on SOP, quality policy, quality objectives, conducting management review meetings and recording the meeting minutes. • Author Quality Manual - Training of Quality Management System Quality Manual to Executive Management - Training of Quality Manual, Document Control and Document Structure to company-wide employees • Initiate and rollout related quality management system documentation - Identified existing documents, present examples for enhancement, administrate release - Train Good Documentation Practices to company-wide employees
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Intrinsic Medical Imaging
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Dallas/Fort Worth Area • Medical Devices
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Quality Systems and Document Control Manager
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Sep 2011 - Jun 2013
Reported directly to the President and CEO of Intrinsic Medical Imaging and has a support responsibility to all functional directors, managers and personnel. • Implemented Quality Management System and Document Control. • Adhered to ISO 13485 for medical devices and FDA 21 CFR Part 820 Standard Operating Procedures creation, controlled release, audit inspections, report, review, and follow-up. • Implemented internal company-wide training for ISO 13485 and FDA 21 CFR Part 820 Standard Operating Procedures, Quality Manual and Good Documentation Practices. • Compiled and provided the instructional training and maintenance of the master training matrix and internal employee training record keeping. • Coordinated Intrinsic Medical Imaging internal-assessment audit performed by DHC Associates, an independent consulting company. Zero non-conformities found during extensive three-day audit. • Executed Corrective and Preventive Action process and managed all associated CAPA records. • Chair weekly Quality System, Regulatory Affairs, and CAPA review meetings. • Authored Management Responsibilities SOP, Mentored Management Review Meetings - Introduced and trained executive management on Management Responsibilities SOP, quality policy, quality objectives, importance of conducting regular consistent management review meetings and recording the meeting minutes. Rolled-out and chaired regularly scheduled quarterly Management Review Meetings of the Quality Management System, maintained attendance records of the meetings and meeting minutes including Quality Objectives and follow-up. Maintained Executive Management Review form template, Meeting template and Meeting Minutes template. • Obligations include interface as the focal point of communication with Quality Software consultant and Regulatory Affairs consultant as required to meet company and customer compliance requirements.
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E4D Technologies
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Industrial Machinery Manufacturing
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1 - 100 Employee
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Document Control Manager
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Apr 2005 - Sep 2011
Reported to the VP of D4D Technologies Operations and had a support responsibility to all functional directors, managers and personnel. • Established and sustained all procedures and processes for maintaining documents and change control of documents. • Determined and enforced through functional groups Document Control requirements in order for the company to meet internal and external needs and standards. • Developed and trained essential employees on ECN process and chaired weekly CCB meetings. • Responsible for implementation and maintenance of the company ERP document control system, reporting on the performance of the ERP document control system for on-going review during applications of system upgrades.
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Air Systems Components
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Richardson, TX
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Configuration Developer
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Nov 2003 - Apr 2005
Reported to the Director of ASC Information Technology and managed assigned projects. • Logia Configuration Management Database Key Member of Configurator Steering Committee. Implementation, maintenance, created training documentation and trained colleagues. • Managed rules-based ERP system beginning with the Sales Order entry processes throughout several product model development concepts and through shipment and delivery to the customer(s Reported to the Director of ASC Information Technology and managed assigned projects. • Logia Configuration Management Database Key Member of Configurator Steering Committee. Implementation, maintenance, created training documentation and trained colleagues. • Managed rules-based ERP system beginning with the Sales Order entry processes throughout several product model development concepts and through shipment and delivery to the customer(s
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Intervoice
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Telecommunications
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1 - 100 Employee
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Configuration Analyst
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1997 - 2003
Reported to the VP of Intervoice Manufacturing. • Managed Oracle ERP product configuration with and for Product Management. • Responsible for download transfer of item master files from one database to another and a key member of Company-Wide Database Conversion Teams including reassignment of items, BOMs and migration of all drawings, documents, software and media. • Liable for company-wide training of Oracle Manufacturing Module encompassing all inquiries, item definition and ECN writing; developed training package(s) targeting copious levels of Oracle skills. • Trained for and performed ISO internal company audits.
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BD
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Supervisor of Documentation Systems
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Jan 1995 - Jun 1996
Reported to the VP of BD Immunocytometry Systems Division. • Developed and administered expense and capital budgets, schedules, process procedures and performance requirements/job descriptions for newly established Document Control Department. • Responsible for and monitored daily work schedules for Drafters, ECN Analysts and Document Control Clerks managing a department of 20 employees. • Established systems and written procedures for the efficient creation, storage, change control and distribution of all documentation necessary for the successful manufacture of product. • Focal point for customer specific requirements, identifying specifications requiring engineering effort and communicated to engineering staff for action. • Negotiated schedules with engineering and manufacturing to meet project requirements. • Worked with purchasing staff to identify valid vendors and sourcing required materials and services, approved vendor listing and applicable spec sheets, data sheets and drawings. • Key member of ISO Coordination Team in implementing ISO 9001 with comprehensive understanding of ISO, FDA and GMP principles. • Receiver of several Department Awards and Becton Dickinson Company Presidential Award recognizing an outstanding contribution of dedication, commitment and teamwork in achieving prosperous Document Control practices.
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Education
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1978 - 1982
West Valley College
A.S. Degree Electrical Engineer, Electrical and Electronics Engineering
Community
