Expert Details

Expert in Quality Assurance, Regulatory Affairs, and New Product Development Consultant

Expert ID: 731924 Illinois, USA

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BS Engineering, 30+ years in senior technical/management positions in Quality Assurance, Regulatory Affairs, and New Product Development space. Expert in medical device, in-vitro diagnostic, and pharmaceutical products and processes. Core competencies in Design Control, Risk Management, Validation and Verification, and Process Improvement. Extensive international internal and external auditing, supply chain, and joint venture management

Directed QA/RA and R&D organizations ($5-10M annual budgets). Deep Project Management experience, from concept-to-post market review. Founded two medical device start-ups.

Founded two medical device start-up companies. Managed multi-year/multi-million dollar R&D projects (concept-to-production). Directed multi-shift, manufacturing QA organizations (SPC, DOE, Expert, CAPA). Consultant for Abbott & Baxter-FDA Remediation and Consent Decree activities. Process development expertise-med device/aseptic assembly, sterilization & packaging. Audited 500+ Component, OEM, and JV Partners in US, EU, and Asia-improved quality and cut costs through intense supplier management and quality training. Cultural Change Agent-successfully transformed Product Development & QA processes. Established & directed Project Management Office at $100M medical electronics firm. FDA Expertise-510(k) Filing, MDR’s, 483 audit & product recall management. Wrote several ISO/FDA-compliant Quality Management Systems (QMS) from scratch.


Consultant for Abbott & Baxter-FDA Remediation and Consent Decree activities.

Expert may consult nationally and internationally, and is also local to the following cities: Chicago, Illinois - Rockford, Illinois - Aurora, Illinois - Naperville, Illinois - Joliet, Illinois - Elgin, Illinois - South Bend, Indiana - Gary, Indiana - Milwaukee, Wisconsin - Kenosha, Wisconsin

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Education

Year Degree Subject Institution
Year: 1984 Degree: BS Subject: Materials Engineering Institution: Columbia University, School of Engineering and Applied Science

Work History

Years Employer Title Department Responsibilities
Years: 2011 to 2014 Employer: Pelstar/Health o meter Professional Title: VP Products Department: QA, RA, Engineering, Technical Service Responsibilities: VP Products had overall responsibility for Product Development, Quality Assurance, Regulatory Affairs, and Technical Support for $20M medical weighing scale firm. Responsibilities included "Next-Gen" product development, supplier quality management, and FDA/CE relationship.
Years: 2008 to 2011 Employer: Rauland-Borg Corporation Title: Director of Regulatory Affairs/Project Management Department: Responsibilities: Directed regulatory compliance activities for a $100M+ Hospital Intercom and Communications firm. Established and directed the Office of Project Management. Accomplishments included: Managed firm’s FDA, MDD/CE, and ROW regulatory relationships. Resolved all outstanding 483 issues from FDA Audits. Managed all MDR issues to completion. Provided in-house expertise for global regulatory compliance, including MSDS, Hazardous Waste, Blood Borne Pathogen, Battery, Energy Star, RoHS/WEEE, and Buy American Act (BAA) Regulations. Brought firm into international compliance. Created and directed the Office of Project Management. Recruited 4 Project Managers, supporting an integrated Project Management and Design Control Process for $10M+ R&D budget, and 65 Marketing/Engineering personnel. Created a formal FDA/ISO-compliant Product Development Process (PDP) under Sr. Management guidance. Converted all R&D projects to a Requirements-based, Stage-Gate, product development methodology. Managed a $2.5KK Mass Notification/Communications project (SW/HW), as well as multiple Far East Joint Venture projects. All products were successfully launched. Initiated cross-functional supply chain teams for complex electronic assemblies, including printed circuit boards, batteries, and semiconductor components. Saved $800K by realigning global printed circuit board supply base.
Years: 2005 to 2008 Employer: Sword Diagnostics Title: Co-Founder & VP Engineering Department: Responsibilities: Co-founded startup diagnostic company, based upon novel Raman Spectroscopy technology licensed from US Naval Research Labs (NRL). Accomplishments included: Licensed proprietary diagnostics instrumentation technology from US Government. Wrote Business Plan, solicited, and raised over $4.0M from venture capital groups. Identified and established joint ventures with outside instrument manufacturers for successful development of a Raman detector and automated sample prep system. Created firm’s Quality Management System, in compliance with ISO/FDA requirements.
Years: 2001 to 2005 Employer: Jonathan Wacks Consulting Title: Consultant Department: Responsibilities: Clients included Baxter, Abbott, and various med device firms. Projects/Activities included: Review of Process & Software Validation protocols (Abbott)). Risk Analysis (RA) SOP development, and employee training (Abbott). Design FMEA, Risk/Safety Analysis-parenteral compounding devices (Baxter). Validation and Verification (V&V) for apheresis system (Baxter). Instructor, FDA Quality Principles, Validation, Risk Analysis. Risk Analysis-Blood Bank Software. Assessed new device feasibility, and developed regulatory approval strategies. Conducted mock FDA audits.
Years: 2000 to 2001 Employer: Medela Corp Title: Director of QA and Regulatory Affairs Department: Responsibilities: Directed the QA/RA efforts for a $100M, nursing/suction medical device firm, with a $1.1M annual budget and a staff of fifteen. Accomplishments included: Managed QA effort for two-shift device operation, including electromechanical and disposable assembly, product packaging, and sterility assurance (EO). Successfully resolved all FDA 483 inspection audit issues. Developed regulatory strategy, and filed regulatory applications for firm’s surgical suction & breast pump products (FDA Class II, 510k non-exempt). Researched, selected, and installed/validated an Enterprise-wide, Part 11 Compliant Electronic Document Management System (EDMS). Developed recall strategy with FDA, and managed recall of neonatal medical device.
Years: 1994 to 1999 Employer: Senetek PLC Title: Director of Engineering and QA Department: Responsibilities: Directed the Engineering and QA activities for a biotechnology drug delivery firm. Managed a $5M Engineering effort, along with a full-time/consultant staff of ten. Supported firm’s parenteral R&D therapies integrated into the auto-injector system. Accomplishments included: Started medical device company, and sold technology and rights to Biotech firm. Awarded multiple patents for novel syringe design and manufacturing. Managed auto-injector program from basic R&D through Clinical Trials and Scale-up. Specified & purchased $1.5M in injection molds, assembly & aseptic filling equipment. DOE, SPC, and V&V expertise in sterile assembly, filling, and packaging operations. Successfully registered ISO Quality Management System with TUV Rheinland. Assembled 25,000 clinical devices at sterile Pharma facilities in UK and Canada. Supported NDA/ANDA submissions for Epinephrine & Erectile Dysfunction therapies.
Years: 1984 to 1993 Employer: General Instrument and IBM Corporations Title: Quality and Reliability Engineer Department: Responsibilities: QA, Reliability, and Failure Analysis Engineering for semiconductor divisions, with facilities in US, Ireland, Taiwan, and PRC facilities. Accomplishments included: Managed failure analysis & device reliability labs (5 employees and $250,000 budget). Successfully approved over 50 devices in automotive, telecom, and military applications. Tested devices per MIL-STD specifications, and assembled PPAP/QPL documentation. Unified global product/process validation system for all manufacturing plants. Wrote numerous quality policies/procedures as part of ISO 9001 certification (DNV). Developed reliability prediction models & environmental test methods, including accelerated stress test (HAST), activation energy, and Weibull prediction methodologies. Provided extensive customer troubleshooting and crisis management support. Performed Failure Analysis for silicon, IC packaging, and PC board materials.

Fields of Expertise

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