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Regulatory and Quality in all medical device classes (1,2,3,4), combination devices, and Pharmaleadership, business, and planning experience with good product successes and profitable outcomes; GMP, MDD, EUMDR, IVD and IVDR experiences, plus Documentation, QC and Materials Management.10167 Celtic Ash Drive Ruskin Florida 33573; EMAIL AVAILABLE, PHONE NUMBER AVAILABLEhttps://LINKEDIN LINK AVAILABLEDepth of Experience18-years Regulatory experience (includes labels, labeling, IFUs and advertising claims)12-Years Quality Assurance experience, and RFI and EMI design/remediation under 6060122-years Medical Device Design experience; 3-years Combination Products CDx10-years in Management; EXPERIENCE in GMP, GLP, GXP (21 CFR 210,211, 800, and 58)14-years Remediation/ Audit experience, US GMP, MDD, EUMDR, (SAMD and SIMD), IVD and IVDR2-years in UKCA experience, 23-years QC experience8-years in class 3 surgical devices/ instruments, PMA, sterility (radiation and EtO), and safety EN6060110-years in Supply chain issues, audit and remediationFormal EducationBS Electrical Engineering- Indiana Inst. of Technology, Fort Wayne, IN;Biology - Saint Josephs University, Philadelphia, PA,MA Biology Montclair State University, Upper Montclair, New JerseyTraining and CertificationsBSI: auditor and assessor training and certifications: ISO 13485:2016, ISO 9001:2015, ISO 14971:2019, Root Cause Analysis, MDSAP, MDD, IVD, IVDR, MDD and EUMDRBSI: Supply Chain methods/SCARS, Risk, Contracts with training in ISO 13485: 2016, ISO 10993, ISO 11135 sterilization ISO 17025 testing and calibrationBSI course in CAPA, Finding the true Root CauseSQA Services: CFR 820 requirements, ISO auditing to ISO 13485NMI USA: CE and CB Scheme Testing and ComplianceUL: ISO 15223-1 labeling, ISO 14971, ISO 10993-XX, and EN 60601, with Design ControlsJohnson & Johnson segregate AMA: Project Management, Interpersonal Relationships, Competent Interviewing and Effective Public Speaking.QSR and GMP/GLP/GXP: develop and execute IQ, OQ, and PQ procedures and SOPs, ISO trained and training and software development/ validation under 21 CFR part 11, Lab SafetyROHS, REACH and RoHS-2 Testing and ComplianceSix Sigma classes; statistical analysis, DMAIC, continuous improvement, Lean enterpriseValidations and verifications instruction under parts 4 and 21 CFR 801, 803, 806, and 820Experience with: Windows 10/11, ORCAD, Microsoft Office, VISIO, PROJECT, MINITAB, SAMD, SIMD, and CDRH requirementsSoftware and Firmware AddendumMedical Device quality and regulatory experience of software within development, verification and validation testing. Experienced with IEC 62304 and 21 CFR Part 11 in ultrasound imaging devices, clinical blood and PCR analyzers; cautery, medical imaging, pattern recognition, machine learning, and system programming. Familiar with International and National standards for the design, development regulation of SAMD/SIMD including efficacy, patient safety and FDA Security Guidance.Quality and Regulatory experience includes CAPA, Complaint handling, PMR and:Quality and Regulatory Management, labels, labelling, and label negotiations, Document Control, Materials Management, QMS documents to GMP, CE mark (documentation, Technical Documents, and process controls under ISO 13485/ EUMDR and IVDR), Audit/Assessor experience, and Risk Management plus 510K / PMA/de Novo applications, orphan drug, post Market Follow-up (under section 522) and Estar.Skills:FDA GMP, MDHA, QSR, QC, Standard Operating Procedures (SOPs), Program planning and launch, Work Instructions (WI), Records, QA, DMR, DHR, DFR, Electrical Engineering, Biological Sciences, Project level systems design and control, Good Manufacturing Processes (GMP), IVD, IVDR, GUDID, UDI, proper Record Keeping, 510K, PMA, ISO 13485, ISO 14971, ISO 15223-1, MDD and (EU) MDR, Risk Management, Safety, Harm Analysis, Supply Chain, SKUs, SCARS, CAPA, Complaints, Labels, IFU, FURLS, MDCG, Root Cause, 60601, SAMD, SIMD, IMDRF, Combination Product, Verification, Validation, advertising claims, Food and Supplements, Pet Products, cosmetics, Project level plan and administration via Microsoft Project, STeD files.Professional HistoryAzur Medical Company, Inc. 6710 Everglades Drive, Richmond, VA PHONE NUMBER AVAILABLERegulatory Specialist, Permanent and Remote: Full time PositionA startup, with Class 1 and Class 2 medical, combination product, food (snacks), supplements and pet products. I wrote, created a full GMP and ISO 13485 QMS, filed a 510K for safety syringes, completed the labels and label documents and label negotiations with FDA, entered the market with Chinese imported product, already CE compliant. My Quality Management system, included production flow pathways, quality documents, I registered the premises, completed FURLS, and employed Risk Management to EN ISO 14971:2019 with A11:2021 requirements, working a PFMEA and UFMEA into our QMS. Results: Entry into markets with 30+ million potential.Integra Life Sciences, Inc. 1100 Campus Road. Princeton, NJ PHONE NUMBER AVAILABLEQuality/Regulatory Lead, Remote: Contract PositionRemediation: Gap assessment, project planning, for company Class 1 and Class 2a product to be updated from MDD to EUMDR. Released UDI Labels, IFU copy for MDR, Technical Documents, and post market surveillance set up along with updates to Risk documents in updates to the Hazard Analysis, User and product FMEAs, for the Risk Management, Risk Plan, Risk Report documents in preparation for a Notified Body (BSI) application for CE under EUMDR. Result completed remediations accepted by BSI.Alexion/Astra Zeneca Pharmaceuticals, 121 Seaport Blvd, Boston MA. 10/21 4/22Quality 4 Lead, Remote: Contract PositionRemediation and obtained CE under EUMDR; for a Combination Product, plus one IVDR device, in an ISO 13485:2016 +A11:2021 environment with submission to an EU Notified Body (NSAI) and I supported a BLA (Biological) application here in the USA. My gap analysis and label negotiations were confirmed acceptable by NSAI in stage 1 review. I worked the labels and label copy and IFU development. Other works included preparing the company for MDSAP for South America and Canada sales. The company SOPs/ WI and structures were updated in change control as Vault Quality, TRACKWISE, and SAP changes were completed and released after the Stage 1 Audit in favor of the Stage 2 assessment of our EUMDR application. Result: NSAI granted CE under EUMDR and CE label (0709 was put on product worth $200 Million in annual sales); after meeting the Low Voltage Directives for the demo devices to allow FCC and a self-declared CE, the demo device was released to marketing/ sales estimated worth 100+ millions of dollars US.BSI Herndon, VA. 5/19 10/21Trained and Certificated Internal, External and Lead Auditor and Certifications AssessorFull Time PositionLead Auditor ISO 13485:2016, Lead Auditor ISO 9001:2015, Lead Auditor for MDSAP (Medical Device Single Audit Program), and in: MDD, IVD, IVDD, IVDR, EUMDR, ISO 13485:2016 as updated and ISO 14971:2019 as updated. My functional work was to visit BSI clients for certification, re-certification, remediation or surveillance audits to document/recommend certificate renewal, continuance, or withdrawal and if discovery of Major or Minor QMS findings, example MHRA label requirements, (ISO 13485:2016 and ISO 9001:2015), closure of any such findings. I also worked in a team completing Phase 1 and phase 2 assessments for IVD, MDD, MDR 2017/745, and IVDR 2017/746 certifications. Results: several CE certs granted/continued and remediations clearing regulatory gaps.NORDSON MICROMEDICS Eagan, MN. 2/18 - 11/18Quality Systems / Regulatory Consultant Contract PositionRemediation: In response to Notified Body adverse findings, I worked CAPAs to closure. After a review of the companys Regulatory and Quality stance. I made updates to the documentation system, worked labels and label copy/ and IFU development, composed risk reports, reviewed validation report, built technical files for 2 new products, and made improvements to the EU technical file of a third product. Work scope also included helping the company implement ISO 13485:2016 and meet MDSAP for Canadian sales. Additional activities included preparing for new product release and compliance to Medical Device Regulation 2017/745 for CE.LIA Diagnostics, Inc - Philadelphia, PA. 10/16 to 4/17Quality Systems / Regulatory Affairs Consultant Contract PositionAfter predetermination meetings with FDA, negotiating labels and Biological interference, but prior to 510K submittal, I wrote a cGMP based QMS including Design Controls, Risk Management, CAPA, Complaint processing, Continuous Improvement, Statistical Methods etc. and composed Test Methods (work instructions) and production forms for records in the DHR; I completed labels and label copy/ and IFU development, started Production of a fully disposable HCG (pregnancy test) with QC testing and production controls. Final work was training personnel under the new QMS whereupon product was allowed to move back into the marketplace.CONMED Corp - Utica, NY. 5/16 to 10/16Quality Systems / Regulatory Affairs Consultant Contract PositionSOP updates for/to Design Controls, Risk Management, Complaint processing, Continuous Improvement, Statistical Methods and Test Method Validations due to QSIT findings. Then processing updated design documents and the risk management records for an updated design, new 60601 testing, including the Design Controls and the design FMEA.I then moved to culling complaints (and searching the MAUDE system) for occurrence calculations and later to aid in qualifying device adverse events per the MDR specification along with filing FDA form 3500A (complaints). Result: FDA release for product to go back to market.Zephyr Technologies, Inc - Annapolis, MD now part of MEDTRONICS Inc. 4/15 to 8/15Quality Systems / Regulatory Affairs Consultant Full Time PositionI was hired to enhance quality systems, and develop regulatory strategies, including creation of documents for CE Mark application. I enhance labels and label copy/ and the IFU development. I reviewed clinical data of and for the 510K application. The device was a telemedicine product for the detection and monitoring of patient vital signs on an outpatient basis and it was released to the marketplace with sales of 8-millions USD.Parker Laboratories, Inc - Fairfield, NJ. 10/14 to 1/15Sr. Quality and Regulatory, Consultant Contract PositionDesign Controls, Risk Management, and 510(k) Applications: I was hired to implement Design Controls and a Risk Management system under their QMS, so we could implement regulatory required 510(k) application (documents) for new products and updates for products already in production (new labels and formulation changes). I prepared and submitted Traditional and Special 510(k) documents.SYNTHES, Inc., a Johnson and Johnson Company - West Chester, PA. 06/13 to 10/14Senior Risk Management, Quality and Regulatory Engineer, ConsultantContract PositionOriginally hired for a limited number of remediation tasks, I had completed upgrades in this area for legacy products where my QMS, ISO - 60601, ISO - 14971:2012 and ISO - 13485:2012 experience and training were put to use. My contract was extended to do software validation, complaints auditing, assist with new 510Ks and CAPA closure to help remediate an FDA letter and bring to market both line extensions and new products.I did labels and label copy.MOBERG Research, Inc - Ambler, PA. 01/13 to 06/13Manager of Quality Assurance and Regulatory Affairs Full Time PositionA startup without a functional QMS, wanting ISO -13485 and CE, to sell EEG instruments on a global scale. The EEG instrument would also correlate other instruments' information (e.g., vital signs), for real time display in an ICU. I established a CAPA program, Complaints system, Training and Management Review Systems also labels and Statistical Techniques. Got FDA premises registration and I instituted a quality records system and clarified the Device History Records (DHRs) and calibration plus ESD test logs, while I visited vendors. End result: a fully functional QMS, with ISO13485 certification under way.SYNERGETICS, Inc EAST - King of Prussia, PA. 03/11 to 12/12Manager of Quality Assurance and Regulatory Affairs Full Time PositionManaged the QC, QA & RA functions at this facility: Revised or completed SOP's, Kaizen, Six Sigma, a 510K, continuous improvement, Lean, risk management, applications to CSA, INTERTEK, UL, vendor SCRF (Supplier Change Request Forms), internal and external audits, training, CAPA, Complaints, Non-Conforming Product and statistics (Pareto of complaints, MRB, CAPA, repairs). I authored a 510K, CE Technical Files/submission and letters to file, and maintained the Device Master Records for products/ reagents. We passed a 7-day FDA QSIT audit- no 483. I worked Ministry (Japan) requirements and I did labels and label copy too. Performed Sterility under ISO 11135 and saw to Gage R&R under ISO 17025.INTEPROD, LLC - Eagleville, PA. 09/08 to 03/11Principal Engineer Full Time PositionThis involved design and production of medical, dental and food safety devices as a team leader. The ultimate aim was to be our client company's contract manufacturer for the systems we designed (for them) including labels and labeling. This position included electronics design but also solving regulatory and quality issues. I worked CAPAs, Complaints, other GMP regulatory requirements, SOP's, work instructions, production travelers, the Device Master Record, ISO13485, ISO 10993, safety ISO60601-1 (UL, CE, CB scheme) and the 510K submission.SQA Services, Inc. Rolling Hills Estates, CA. 09/06 to 09/08Quality Engineer and Auditor Full Time PositionAuditing for ISO 13485, GMP, ISO 14001, ISO 10993 ISO 11135 and ISO 17025 as an internal and external auditor for/at Stryker Inc., Mahwah, NJ, I worked removal of non-conformances, CAPA issues and assisted with remediating QMS 483 issues, along with completing audit reports, visiting vendors for audit and recommending vendor solutions. Thereafter, I completed external audits for various SQA client companies.PURICORE Inc - Malvern, PA. 10/03 to 09/06Product Engineer/ Team Lead Full Time PositionAn international company where I helped pass a 6-day QSIT FDA audit (no 483). Effort: design and move to production sterilization fluid generation equipment. The fluids are Chlorine based, used to protect foodstuffs and also disinfect returned medical, pharmaceutical, and dental equipment. Design included Analog, Digital and Microprocessor circuitry, and I composed portions of the 510K application. Product met UL, MDD and GMP requirements. Production with sales topping $13 Million. I managed 5-contract manufacturers and helped maintain product while working on new designs and meeting Quality and Regulatory requirements.IMMUNICON Corp - Huntington Valley, PA. 10/02 to 10/03Principal Engineer Full Time PositionJoined a team and transformed an engineering prototype medical instrument for the identification of cancer cells in human blood tissue into a finished medical instrument. Final (re)design included low noise amplifiers, microprocessors, FPGAs, and optics; I wrote SOPs, travelers, and I redesigned system cables and harnesses for low EMI/RFI operations. I completed system labels and a Technical File for CE; once I completed that work, this device went into 100+ millions production.MOLECULAR CIRCUITRY Inc - King of Prussia, PA. 4/00 to 5/02Program Manager Full Time PositionI was group leader for production of an instrument that detects pathological bacteria in foodstuffs. I moved this instrument into QSR based production, and documented instrument test and assembly, labels and labeling, obtained UL, CE, GS, CB Scheme and other marks while administrating "Follow-up". I completed CAPA and complaint forms and filed with regulatory authorities.SMITH'S Industries - Malvern, PA. 10/99 to 4/00Senior Electrical Engineer Contract PositionA stopgap position in helicopter avionics using my design skills in electronics circuitry.NUMAR Corp - Malvern, PA. 5/98 to 10/99Senior Electrical Engineer Full Time PositionAt this company we produced an MRI based instrument to map oil pockets underground. I designed, built and installed a radio transmitter that relayed back to the surface the depth underground of the main mapping instrument.INNOVASYSTEMS, Inc - Pennsauken, NJ. 10/92 to 5/98Systems Consultant Project Leader Full Time PositionContracted for design needs of various companies. One contract was with an IC bonder company, where I designed upgrades to bonding equipment that included analog and digital circuitry. Designs were then scaled to work for larger bonders as INTEL parts grew in size and complexity. Later contract designs involved electronics design for Inhalation therapy metering, Shampoo clarity and viscosity testing with time, cleaning agent cloth spot detection, and an artificial stomach system for the measurement of tablet dissolving rates. These designs were for various pharmaceutical companies. In some cases, I wrote the installation documents (IQ, OQ and PQ documents) and I helped install the devices at the client's site.THE JADE CORPORATION - Huntingdon Valley, PA. 9/91 to 9/92Senior Engineer Full Time PositionJoined a team and designed analog and digital circuitry including microprocessors, amplifiers FPGAs and simple logic integrated circuits for floss threading devices, incontinence diapers, and contact lens production equipment for J&J companies. I also designed safety circuitry for an IBM IC wafer production oven that used corrosive and life endangering etchant gases to produce digital memory. I helped write IQ, OQ, and PQ documents and helped install the equipment at J&J facilities and at IBM facilities.INNOVATIVE MEDICAL SYSTEMS, Inc - IVYLAND, PA. 2/91 to 9/91Senior Product Engineer Full Time Position(Program Management with 37 "reports": Program level responsibilities included interface with partner pharmaceutical company's management, project planning, etc. This project, a high-speed clinical blood analyzer, was canceled after a review point where funding was lost.SONIC TECHNOLOGIES, Inc - Horsham, PA. 9/89 to 2/91Manager of Electrical Engineering Full Time PositionProgram Management with 7 "reports", leadership and responsibility for instrument development, and first-article production: Accomplishments included design and development of a lithotripter (kidney stone crusher) used under contract to test disposables, and an FDA 510K approved ultrasound, QA, 1.2-Gigahertz ultrasound probe that was designed, tested and placed into QSR production.JOHNSON and JOHNSON, IOLAB/SITE MICROSURGICAL - Horsham, PA. 2/86 to 8/89Senior Engineer, Group Lead Full Time PositionProduction of a Class 2 eye surgical instrument for cataract removal and lens replacement {Class3}; this with a full QSR system; I wrote work instructions, SOPs, handled IFU, labels and packaging issues, and saw to compliance of the Technical File for both UL and CE. This company passed a 5-day FDA audit (no 483).ELECTRO-NUCLEONICS Inc - Fairfield, NJ. 1/82 to 2/86Senior Electrical Engineer Manager/Team Lead Full Time PositionProduct line was clinical blood analyzers; A new linear clinical chemistry Instrument was completed and taken to FDA/QSR production; this included a complete line of liquid reagents. My work included system, program, and project responsibilities and the implementation of documentation and controls at first production run. This program brought to production an automated analyzer that yielded $350,000,000+ in sales. I program managed a redesign group to obtain a 30% reduction in production cost. Company passed a 7-day FDA audit, I obtained UL544, and completed 3 Follow-up Audits here.TECHNICARE, SPECIAL RESEACH GROUP, a J & J Co.)-Somerset, NJ. 2/79 to 1/82Design Engineer Full Time PositionI was Product Lead for system safety. We designed and developed a diagnostic, ultrasound, imaging device for detection of breast cancer. I did analog (amplifier, filter, A/D), digital (LSTTL) circuits and some 8031-assembly software. Prior to production, I obtained UL listing for the instrument, and then did the electronics design of a processor based, high-definition cross-section image player for post examination, physician review, and a 16-step gray scale (analog & digital) onscreen generator for real time system performance evaluation. At this company I received GMP training and we passed a 5-1/2-day FDA and CDRH audit. |
