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Engineer Quality

Cincinnati, OH
March 29, 2021

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Diane Icard

**** *********

Cincinnati, Ohio ****7

Ph: 513-***-****



An accomplished and dedicated quality/validation solution driven individual that encompasses pharmaceutical (21CFR 210, 211 & ICHQ7a) medical device (21CFR 820, ISO13485 and MDSAP) engineering applications. Originated and implemented several customer-driven new product designs through production in both pharmaceutical and medical device projects. Hosted Corporate, Health Canada, FDA and TGA audits. Project managed technical transfers of regulated pharmaceutical products with their associated data migration from several international companies into the parent company residing within the US. A creative blend of analytical and technical knowledge of integrating cGMP quality aspects into diverse pharmaceutical and medical device manufacturing processes.

Altabrisa Group L.L.C. Sr Quality Consultant (Remote) Jan 2020 – Present

Data integrity analyst for a pharma company in New York which has recently been cited by the FDA for submission of inaccurate, data management. Duties include review of stand-alone systems for raw material, bulk, finished good, packaging and labeling. These reviews include obtaining and verifying instrument data, audit trails of equipment used. Verification of standards, materials used in the processes as well as routine verification of scales/balances, FTIR, FTNIR, specific gravity, pH, for daily logs and daily calibration checks.

Customer complaints were re-evaluated for criticality levels, adverse events reporting, responses to clients and individuals and determinations made to initiate non-conformances and corrective actions that need to be made by the manufacturing company.

Guerbet L.L.C Supplier Quality Project Manager March 2018 – Oct 2019

Maintaining supplier evaluations, audits of various raw material suppliers of machine shops, PCB manufacturers, plastic injection molded components. Audits of calibration houses, laboratories, including EtO sterilization services. Supplier corrective/preventative action initiation and maintenance from non-conforming material reports for Urology specific Class II medical device company. Internal audit scheduling, maintenance, and training of junior auditors for the MDSAP ISO-13485 criteria. Reported KPI and metrics quarterly. Initiating Supplier Quality Agreement with our critical level 1 and level 2 suppliers.

Philips Healthcare Supplier Quality Engineer Consultant/Project Manager__ Feb. 2017 – March 2018

Coached and managed Philips Supplier Quality Engineers and suppliers ensuring their competences met Philips requirements due to a Consent Decree which 2015/2016/2017 supplier quality remediation effort for AED (automatic external defibrillators), Class III medical device.

Ensured that the assigned supply base met the Philips product quality, regulatory and business requirements. Reviewed the quality performance of the assigned suppliers via quality reports and quality audits. Verified corrective actions and effectivity from previous surveys, audits observations or actions from performance improvement plans. Determined whether Supplier non-conformances were identified and should be escalated to a SCAR.

Emma International Supplier Quality Engineer Consultant Remote Jan. 2016 – Oct 2017

Similar supplier evaluations as conducted as below, however working remotely. More onsite audits of critical suppliers to meet the guidances of TS 16949 and ISO 13485 within the US, Mexico and Canada. Establishing documentation for Supplier management, Reach/RoHs and Conflict Minerals, supplier score cards, and supplier metric evaluations. Year to date: 20 onsite quality audits per ISO-9001-2008, ISO13485/21CFR 820, TS16949.

Philips Healthcare Supplier Quality Engineer Consultant/ Project Manager Jan. 2015 – May 2015

Prepared and executed Supplier audits utilizing the Philips Supplier Evaluation and Assessment Tool (SEAT13 software) to ISO 9001-2008. Coached and managed suppliers ensuring their competences met Philips requirements due to a citation included within the 2014 remediation effort for Ultrasounds, Class II medical devices.

Ensured that the assigned supply base met the Philips product quality, regulatory and business requirements. Reviewed the quality performance of the assigned suppliers via quality reports and quality audits. Verified corrective actions and effectivity from previous surveys, audits observations or actions from performance improvement plans. Determined whether Supplier non-conformances were identified and should be escalated to a SCAR. Evaluated process steps from initiation of a SCAR to verification of the effectiveness of the implemented actions and documentation of objective evidence in record and closure of the SCAR. Year to date: 15 onsite and 20 desk audits

Hill-Rom Project Manager for QA/RA Investigations (Consultant) _May 2014 – Oct. 2014

Responsible for the remediation effort within complaints handling specifically for hospital beds which are now classified as a Level one (1) medical device. Working as a Quality Assurance/Regulatory Affairs representative with Engineering and Post-Market Surveillance to prepare gap analysis in order to consolidate complaints and close out quality compliant engineering investigations with or without RMA product available. Verification of test methods used to duplicate the product failures when RMA were available. Responsible for confirming information within the DFMEA, PFMEA, and Risk Analysis of the different beds and their components; the basis for the investigation rational if components were not ascertained from the field. Assisting R&D in generating a Complaint evaluation tracker system that will be used to code identify the failure mode/ root cause of the complaints. Acting as the QA/RA representative for documenting justifications when the alleged complaint is deemed a service request or other non-complaint entity.

Maquet (Getinge Group) _ Senior Complaint Consultant Dec. 2013 – Apr. 2014

Responsible for the remediation effort within complaints handling specifically for the Cardiac Assist products. Worked with the field service engineers to obtain the information and entering them in the PSSD database. If more information is needed to describe the event, follow up with the service engineer or clinical staff was made to fully investigate the complaint and or RMA products from the field. Once determined that the event was considered major or critical in nature, a MDR (Medwatch form FDA 3500A) would be written for electronic submission to FDA. In the event that the complaint was not major or critical, a justification would be written to support the basis to investigate a Level 1 complaint as non-reportable.

Novartis Consumer Health (OTC Canada) Senior QA Consultant __ Jan. 2013 – Dec. 2013

Conducted gap assessments to determine quality compliance of annual product reviews, complaint investigations, and product stability compliance and documentation. Develop and update as per GxP requirements Annual Product Review Files for Pharmaceutical and OTC products. Reviewed batch records, implemented change controls, investigated customer complaints. Acted as Interm Stability Project Manager for NCH OTC Canada division (included was 148 different SKUs of product; oral solid dose, liquid dose, capsules and topical cream) until the transfer along with change control of the Canadian stability program was facilitated to Third Party Organizations Analytical Services Novartis CH OTC Headquarters. Authored new SOP’s, stability protocols and assay and microbial stability specifications for laboratory testing. Interacted with TPO's from Canada, Europe, India, and US the areas of stability, analytical method validation, OOT & OOS reviews from third party laboratories and Annual Product Quality Reviews (APQR's). Acted as Canadian operations liaison to work with the process validation team for new product analytical assistance with launches within Novartis Canada.

Monosol Rx Senior Cleaning Validation Consultant_ June 2012 – Nov. 2012

Cleaning Validation consultant for the development of protocols for quality compliant cleaning validation methods, analytical testing methods and training of operation’s personnel the new protocols for a thin-film DEA regulated drug product. Interfaced with the Micro and QC off-site laboratories with test method validation, laboratory test reports, labeling documentation and the execution of cleaning validation. Inclusively updated SOP’s with clean and dirty hold times also established defined the hardest to clean areas per equipment. Subsequently, added more cleaning steps if needed and revised the SOPs for clarity of the new cleaning procedures.

BenVenue Laboratories Senior Cleaning Validation Consultant Apr. 2012 – June 2012

Project management consultant for leading the training effort of the Cleaning Validation protocol, Aseptic Sampling methods to junior personnel. Cleaning Verification and validation consisted of Mixers, pumps, tanks, valves, propellers that were used in sterile applications of chemotherapy injectable.

Wrote statistically sound sampling/ testing protocol with quality engineering personnel to categorize them into 3 separate procedures depending on the size of the parts.1) Cleaning of tanks from 30 gal to 500 gallons with or without spray ball applications. 2) Parts washer cleaning for smaller parts that is computer controlled using WFI with CIP 100 and CIP 200 for detergents. 3) Manual wash for parts that were too large for the parts washer yet need to be cleaned due to drug loading. The method that was used to gather samples was rinse samples taken for Micro, TOC, HPLC testing determination of any residual components not removed. Wrote operator instructions for the decontamination, cleaning, determining the best configuration of the parts while cleaning.

CareFusion Senior Quality Engineer Consultant Oct. 2011 – Apr. 2012

Acting as a quality /design engineer for a Medical Device/ Pharmaceutical combination company specializing in pre-surgical antiseptic applicators for the medical /pharmaceutical hospital industry. Conducted gap assessments on two pre-surgical products that have been cited by the FDA in previous audit as being unsafe for use by the hospital staff and patients. Specifically worked with marketing on proper documentation from Voice of the Customer (VOC) protocols, design verification engineering tests for pre-validation efforts for the new design. Incorporated DFMEA, AFMEA’s and Critical Quality Attributes (CQA’s) in development of a new design change for the existing product.

Validation efforts including upgrades of Clean rooms and USP Purified water systems for formulation of the actual liquid antiseptic drug. Revised the Design History Files based on findings during an evaluation of past products which were lacking information for the next FDA inspection. Wrote a Facilities Security Plan profile for the company, worked with supplier management to correctly identify the BSE/TSE needed information on incoming raw materials.

Ikaria Holdings Validation and QA Consultant Apr. 2011 – June 2011

Quality/Validation consultant for a Medical Device/ Pharmaceutical combination company specializing in NO gas for the neonatal and COPD medical /pharmaceutical hospital industry.

Have created databases for Critical Change control and maintained weekly resolution meetings with Engineering, Validation, Distribution, Information Technology, Quality, Risk Assessment, and Regulatory for these changes.

Validations efforts in-order to resolve issues associated with their Regional Service Center data information. systems, blueprints, and preventative maintenance and calibrations after FDA & TGA inspections.

Wrote a URS/FRS and IQ/OQ for a Shrink-wrapping device for the internal labeling of cylinders.

Combined SOPs for the labeling/shipping aspect of the device to incorporate proper documentation and process mapping of the labeling / packaging operation.

Luminex QA Specialist Consultant Oct. 2010 – Apr 2011

Provided staff augmentation assistance to the upgrades to the Quality Assurance group during their upgrade and change of their documentation and computer systems. Current systems in place were Epicore and ETQ Reliance to change over to Master Control computer software.

Compliance Insight Compliance Specialist Feb. 2010 – Oct. 2010

Responsible for contract Pharmaceutical, Medical Device and Dietary Supplements

Have audited per ISO, FDA and ICH Q7a guidance’s within the US, Europe and Asia.

Experienced in cGMP auditing of Analytical laboratories, Water for Injection Systems, API manufacturers including 21 CFR parts 210, 211 and ICH Q7a

Food Facilities 21 CFR part 110 & 111

Medical Device 21 CFR part 820 & ISO 13485, ISO 14971, ISO 14644, ISO 17025 ISO 17655

Sterilization with EtO and Gamma: ISO 11137-2: 2006 - Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose ISO 11737-1: 2006 – Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of micro-organisms on products.

ISO 11737-2: 2009 - Sterilization of medical devices – Microbiological methods – Part 2: Tests of

sterility performed in the definition, validation and maintenance of a sterilization process.

For Autoclaves: ISO 1766501 Part 1 Sterilization of health care products— Moist heat—Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices Approved 9 December 2005 Now this guidance has been re-approved in 2013.

Xanodyne Pharmaceutical QA Associate Mar. 2010 – June 2010

Responsible for QA /FDA compliance for a Virtual Pharmaceutical company. Documented product complaint and adverse events submissions. Technical and quality review of master and executed drug batch records and analytical lab reports, evaluated and dispositioned deviations, OOS, and OOT investigations. Wrote new SOPs and publishing of the documents via computer program PharmaReady.

Best Sanitizers Inc Project Manager/Validation Engineer Nov. 2009 – Mar. 2010

Responsible for FDA compliance of validation efforts on a collaboration effort with Olympus for a Class II endoscopic medical device to ISO 13485 in the US and Health Canada as a drug product.

Wrote the Validation Facility Master plan for the Best Sanitizer facility & Cleaning Validation Master Plan for CIP/SIP cleaning of equipment. Wrote of the Validation Installation/Operational equipment protocols for a DI water system, Blending system and Automatic bottle filling system. IQ, OQ, PQ.

Wrote the Performance/Process protocol to verify that the entire system operates in a consistent function and to ensure reliability and repeatability of the operations.

Worked as a validation engineer in a collaboration effort with Proctor and Gamble for a three new sanitary soaps and dispensers to be marketing planned for April 2010.

Wincom Inc. Regulatory Compliance Director Jan. 2009 – June 2009

Responsible for ISO-9000 compliance of Wincom Inc. a chemical manufacturing company specializing in corrosion inhibitor and wastewater treatment systems. Wrote documentation for SOP’s, Facility Master Plan, and Quality Manual. Reviewed and approved Batch records relating to corrosion inhibitors manufacturing batch records. Worked on obtaining ISO certification for the facility and developing analytical methods for the laboratory. Coordinated all Regulatory documentation such as: EPA Tier II submissions, OSHA, DOT Reach program, worked on developing a collaboration with a US company to furnish products that are currently manufactured in China.

Girindus America Senior QA Associate Apr. 2005 – Jan. 2009

Responsible for cGMP compliance of Girindus America a pharmaceutical company specializing in oligonuclotides for oncology applications and Small Molecules/Pilot plant for Phase I/II /III projects.

Wrote SOP’s, Facility Master Plan, Cleaning Validations for CIP/SIP documents, Temperature Mapping, Validation of ovens. Conducted IQ/OQ Qualification of laboratory equipment and instruments and retrospective Oligonucleotide add-on facility and verified FAT and SAT documents from suppliers for new equipment. Reviewed and approved Batch records, Deviations (including OOS and OOT investigations) and CAPA’s relating to Small Molecule, Pilot plant API’s and Oligonucleotide manufacturing (which are sterile injectables). Reviewed and approved QC finished product testing HPLC, GC, FTIR, LC-MS, Ion-Chromatography, heavy metal content, residue on ignition testing. Conducted external supplier and customer audits of amidite suppliers, WFI suppliers and contract laboratories. Participated in a three-day FDA Quality systems audit in Feb 2007 as second chair to the QA Manager. With a result of “No 483, and No objectionable items”. Wrote and assisted in the validation execution IOQ from Millenium Computer Software upgrade to Empower software for the Quality Control LIMS system.

Buffers and Biochemicals (BBC) Regulatory Compliance Manager __ Sept. 2002 – Apr. 2005

Also Genesis Chemicals Inc.

Responsible for cGMP quality compliance of BBC and ISO-9001 compliance of Genesis Chemicals.

QA management including cGMP, Batch Record review and release. QA manual & SOP origination and training of staff. Manage cGMP compliance audits documentation and site visits including supplier and internal audits. Conducted cGMP validation encompassing IQ/OQ & PQ along with Cleaning validations of reactors and transfer equipment and conducted and stability studies.

Submitted CE registration packages for pharmaceutical buffers – HEPES, MES, MOPS. Coordinated documentation and site visits with outside regulatory agencies such as EPA, OSHA, FDA and MSD. Certified Hazmat Tech.

Hohman Plating & Mfg Quality Engineer/NQA-1 Cert. Lead Auditor Mar. 2000 – Apr. 2002

Responsible for quality implementation of the Dept. of Energy Getter Tube Project at Hohman Plating.

Originating NQA-1 Implementation Procedures to be used at Hohman for the plating of Getter Tube production that are used in the synthesis of Tritium within nuclear reactors. Have obtained a DOE L-2 security clearance -- Sept. 2000. Certified to audit QS-9000, ISO-9000, NADCAP, and NQA-1 internally, also conducted outsourced supplier audits. Wrote the in-house Quality Manual and Implementation procedures based on the 18 criteria of NQA-1 along with sampling plans and calibration techniques.

Developed testing parameters to insure uniform nickel coating thickness and coverage. Managed and instructed inspection personnel on X-ray fluorescence and calibration. Conducted FMEA and DOE studies for process improvement of Getter Tubes.

Lockwood Greene Engineers Pharmaceutical Validation Engineer June 1999 – Oct. 1999

Responsible for the validation of equipment, architectural, HVAC systems for Pharmaceutical Corporations.

Developed IQ, OQ and PQ validations with Duramed Pharmaceuticals on a project encompassing their new HVAC system and remodeled area for their Estrogen Replacement Therapy drug. Assisting in Smith-Kline Beecham equipment validations IQ/OQ/PQ (blister packaging and bottle filling) machine during a transfer from one building to another in efforts of streamlining the processes. Wrote a Facility Validation Quality system master plan for process equipment, laboratory instruments, and facility utilities for Roche.

Ethicon Endo-Surgery Process Engineer Feb. 1995 – May 1999

Responsible for a Teflon lubricant conversion project which encompasses cleanliness of the components and chemical processing parameters to enhance product functionality. All products were ETO sterilized prior to point of use. Batch records of sterility were obtained and evaluated prior to release of components. Identified current cleanliness/lubrication baseline requirement for product functionality.

Incorporated biocompatibility testing, friction coefficient testing preliminary functional testing for metal and plastic components. Instrumental in purchase and design of new equipment design to enhance the process and enable it to become automated and ergonomically correct. Validated new equipment IQ/OQ and processes PQ & PV CFR 21 part 820 requirements. Organized 510K submissions for new products, processes and submitted European conformity certifications per CEN for products sent to Canada & Mexico.

Hill-Rom Senior Manufacturing Engineer 1990 – 1995

Engineer responsible for welding, assembly, paint and electroplating finishing for a hospital manufacturer. Maintained compliance of GMP, and ISO-9000 for the above production areas and implemented SPC integration. Conducted testing of RMA for information to be incorporate into DFMEA and PFMEAs and Risk Analysis values for the returned goods inventory characterization.

Conducted cost analysis and savings to bring in-house the manufacture of the Stretcher interveneous poles, sideguards, and new Ambulatory Care Stretcher, annual cost savings to the company $ 500,000/yr.

Conducted time and delay studies in the areas of laser cutting, stamping and other fabrication processes.

Interfaced on new product development teams- New Generation Purpose Stretcher, Affinity Birthing Bed and a four-motor Med-Surg Bed. Developed preventative maintenance, calibration requirements for equipment. In the areas of assembly, managed cycle time reduction, lot size reduction and first-pass yield improvements

University of Southampton (UK) Certified Finishing Electroplater - since 1990

Master of Business Administration Certified Eddy-Current Level I & II Inspector - 2001

University of Cincinnati Certified NQA-1/ISO Lead Auditor - 2000

Bachelor of Science

Concentration: Chemistry

SPC Certified by G.E.A.E.B.G. Ergonomic Design for Manufacturing

Hobart School of Welding (Mig) Taguchi Experimental Design

Geometric Tolerancing RCRA/SARA Compliance

Regulatory Affairs 101 Clean Air Act 1990

DOT Hazmat Trained OSHA Hazmat Technician Level II

Cleaning Validation Seminar given by IVT in 2006

Dr. Wayne Taylor Statistics Course using Minitab, Statgraphics and JMP, Feb. 2012

Computer Software knowledge:

Visio, Statgraphics, Minitab 6.1.1 for Statistics

ETQ Reliance-for electronic document control and electronic signatures – Medical Device

Agile (Oracle based) electronic document control software – Medical Device

Pharma-ready-for electronic document control and electronic signatures – Pharmaceutical products

MasterControl -for electronic document control and electronic signatures – Pharmaceutical/Medical device Trackwise - for electronic document control and electronic signatures – Pharmaceutical products

CRTS – Complaints Database for electronic document control and electronic signatures – Pharmaceutical products

SHAPE-SAP product allocation system, Fusion-SAP product allocation system

PSS Database for medical device complaint handling,

SEAT13 Database: for Audits, Self-Assessment Questionnaire, Supplier Surveys & Audit Reports

Made to Manage database for Purchasing, Inventory

MetricStream – SCAR database

JDE & BPICS inventory and non-conformance tracking systems

Spectrum, OPUS, Empower, Perkin-Elmer, LIMS – Laboratory software

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