Expert Details
Quality Assurance, Regulatory Affairs, and New Product Development Consultant
ID: 731924
Illinois, USA
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, MRB, 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.
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 |
|---|---|---|---|
| Years: 2022 to Present | Employer: Undisclosed | Title: Principal | Department: |
Responsibilities:1/22 - Healthcare Consultant• Provides Quality, Regulatory, and Project Management Consulting Services. Projects Include: 9/22 - Vantage Specialty Chemicals (Regulatory Project Manager, API) • Managed plant-wide quality/regulatory transition to Active Pharma Ingredient mfg. • Implemented a full QMS update to ICH Q7/Q13 and CFR 210/211 requirements. • Managed 13 workstreams, including IT System, Process, and Test Method Validation. 1/22-8/22 - Sword Bio, Chicago, IL (QMS/GLP Consulting) • Updated an RUO diagnostic firm’s QMS for GLP compliance. • Formalized Product Development Process (PDP) for kit development and validation. 1/22- General Healthcare Consulting • Short-term consulting (Includes Due Diligences, Training, and FDA Remediation). • Authors various drug/device-related newsletters and articles. |
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| Years | Employer | Title | Department |
| Years: 2018 to 2022 | Employer: Flexan | Title: P QA/RA | Department: |
Responsibilities:Directed the QA/RA strategy for a Class II/III Contract Manufacturing Organization (CMO). Aligned and updated the global QMS to support Tier I implantable medical device outsourcing.• Managed Quality Groups at all four Business Units (45 Managers, QE’s & Inspectors). • Successfully passed three FDA audits in the past 21 months. • Installed a phase-gate NPI system to streamline OEM manufacturing transfer. • Created an aligned global Validation and Verification and Risk Management process. • Provided senior leadership support for successful company sale to a private equity firm. |
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| Years | Employer | Title | Department |
| Years: 2014 to 2018 | Employer: Silk Road Solutions (Healthcare Consultant) | Title: Principal | Department: |
Responsibilities:Quality Assurance, Engineering, and Project Management Consultant• Set up Combination Drug/Device QMS and NPI system for the firm (21 CFR 820/4). • Created DHF deliverables for three generic drugs, from Design Input to Human Factors. • Developed novel drug-device packaging, from prototype to production (patent issued). Baxter Healthcare, Deerfield, IL • Managed global label copy of Class III Biosurgery product line in preparation of the Baxter-Baxalta split. Zimmer/Biomet, Warsaw, IN (Trauma) • 483 remediation support-managed FDA mandated label copy and UDI updates. • Reviewed 100+ 510k submissions, and performed product gap analysis. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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Fields of Expertise
device, device product development, medical device product development, medical injection process, new product development, regulatory affairs, syringe, in vitro diagnostics, medical diagnostics, pharmaceutical product development, pharmaceutics, analytical data quality assurance, quality assurance, quality assurance management system, quality assurance project plan