Summary of Accomplishments with Cultural Change, Quality System Implementation, Cost Savings and Consumer OTC Product Overlap:
- As a consultant/agent of change, drove remediation of quality and compliance issues at a contract manufacturer of a “Dietary Supplement.” Negotiated this through clashing cultures of food processing (21 CFR part 110) at the contract manufacturer and pharmaceutical manufacturing (21 CFR part 210 & 211) from the OTC pharmaceutical client. Drove result to match the actual applicable regulation, 21 CFR Part 111, Current GMP, for Dietary Supplements.
- Remediated 179 MDSAP nonconformances and underscored importance of compliance, at an Intraocular Lens manufacturer, completed within 5 months. (Company culture originally valued very low-cost operation over compliance. However, there was no perceivable increase in operating cost after achieving compliance.)
- Formally trained in special 10-month management program (BAMM, Becoming a Medtronic Manager, at Medtronic Spinal and Biologics), including change management, communication across cultural and personality differences, and managing conflict.
- Establishment of Quality Systems:
- Mapped business processes and re-wrote procedures for contract manufacturer to the medical device industry.
- Mapped and re-wrote the Design Control & Risk Management processes for a startup company producing and manufacturing a Health Assessment Kiosk, installed in drug stores. (Markets include consumer products and medical device.)
- Led a cross-functional team of client personnel implementing a corporate level Strategic Supplier program.
- Controlled design, development and release to market for contact lens and lens care products (Consumer products, medical device and pharmaceutical regulations to be followed.)
- Facilitated Kaizen events to implement a corporate level Dock to Stock program
- Pushed AQL/Cost reductions (Synthes) with team savings at approximately $111,000 in 2004 (additional, personal savings beyond AQL reductions at $38,388 and $61,811 in 2003 & 2004 respectively,)
- Employed Cosmetic Standards contributing to 10% reduction in cosmetic nonconformances.
- Project lead for getting Notified Body approval for an ISO Class 7 cleanroom, completing cleaning validation, validating packaging and re-performing sterilization validation.
- Re-wrote Risk Management procedure and Risk Management Files to comply with ISO 14971:2012 and integrated it with the Quality Management System per ISO 13485:2016.
- Planned next revisions to the Risk Management procedure to comply with ISO 14971:2019 and EU MDR requirements. Also performed Initial EU MDR gap assessment for a Power Surgical Accessories OEM.
- Assisted with writing protocols, executing, writing reports, reviewing and approving validation of processes transferred from CA to GA.
- Wrote project plan and led cross-functional team of client personnel implementing a Strategic Supplier program, converting 80% to Dock-to-Stock at large OEM. (Assisted 2-audits in Germany, as sole German speaking auditor)
- Negotiated Quality Agreements with 12-Strategic Suppliers for the client.
- Put team of 3-consultants in place for CiNQ Systems to integrate inspection requirement documents from two acquired companies. Worked with attorneys and the client to negotiate subcontractor contracts, General Service Agreements and Statements of Work (SOWs.)
- Guided a Defect Review Board toward closing over 200 defects under remediation at a large Advanced Molecular Imaging, capital equipment company.
- Mapped business processes and wrote procedures for instrument Loaner Services Department at a large orthopedic OEM, operating at their Global Distribution Center. Included operations for receiving, cleaning, RFID handling, inspection, nonconforming material handling, rework, and shipping of customized instrument trays.
- Assessed and prepared a client for FDA inspection and subsequently handled the inspection. Highlights include:
- Remediated a Warning Letter for a small startup company, acted as the liaison with the U.S. FDA and achieved receipt of a Close-Out Letter for the Warning Letter.
- Project Manager and Account Manager for a third-party consulting company, leading and managing 9-consultants in pharmaceutical quality systems, with responsibilities in both the U.S. and Canada.
- Mapped business processes and re-wrote procedures for contract manufacturer.
- Assessed Austrian contract manufacturer making recommendations to handle FDA inspections (required German)
- Project Leader for Medical Safety Department, implementing a TrackWise software system upgrade.
- ISO 13485 Registration with BSi
- Management Representative for the quality system audits and the Technical File audit with BSi.
- Implemented processes and procedures for complying with Health Canada.
- Implemented procedures for creating and managing Technical Files and applied for CE Mark.
- Fielded questions and assisted negotiation of regulatory pathway with BSi and the MHRA, in the U.K.
- Directed structure of Design Review, Risk Assessment & investigation of clinical trial adverse events
- Drove an alternative plan to avert an 8-week production delay in getting implant inventory in time for surgeries in the clinical trial. Result: no missed surgeries in the clinical trial
- Design & employment of:
- Managed a Supplier Quality team that established, maintained and monitored quality requirements for 500+ suppliers across five Medtronic facilities; in the U.S., Puerto Rico and Germany. Scope: medical device, tissue, biologics and pharmaceuticals. Responsibilities:
- Managed 6-direct reports and led design quality engineers through the product development process with division-wide projects.
- Hired 4-new Design Quality Engineers (DQEs.)
- Directed DQEs covering 60-active projects. Mentored associate level engineers achieving CQE certification.
- Plant wide responsibility for leading quality projects, product line extensions and driving corporate quality objectives in a Lean Manufacturing environment.
- Project Leader for corporate wide improvements.
- Project Leader for plant wide improvements and led quality improvements in 3-JIT Manufacturing Cells
- Launched 4-products & implemented production workstations by leading 6-crossfunctional teams.
- Commercialized 2-Novoste Beta-CathTM System 5F XL Catheter products, increased revenue by $90,000 per month. Launched on schedule, within 11-months, including 6-month FDA review.
- Led design, development and implementation of cutting and skiving fixtures; and re-launched the 3.5F Beta-Rail™ Catheter, after a voluntary recall. Done in 52-calendar days halting a $1,000,000/wk loss
- Commercialized 2-radiation protection products, 1-calibration block and 1-emergency response kit
- Reorganized the design control system resulting in 0-nonconformances in 2-ISO 9001 surveillance audits and the first FDA PMA audit of Novoste.
- Implemented department metrics: number of changes “before vs. after” design transfer, intellectual property disclosures, number of patent applications and design phases completed vs. time
- Created MS Access database managing & trending complaint investigations and the Material Review Board.
- Infused process control requirements into a craftsman culture, by leading senior management through clashing cultures of a German owned, Dental instrument manufacturer (Brasseler USA) to comply with 21 CFR Part 820, as fulltime Technical Director. Implemented first complete Quality System for that site.
- Wrote and implemented Quality Systems in 3 Startup orthopedic OEMs, with marketing/sales culture and having no manufacturing/operations experience.
- Wrote and advised implementation of a Quality System at a startup importer and distributor for an Italian OEM of a physiologic movement analyzer.
- Assisted implementation of a Quality System at a general surgical instrument manufacturer, as fulltime Quality Engineer.
- Implemented Purchasing and Supplier Selection and Approval system & procedures resulting in zero 483 Observations against 21 CFR Part 820.50 Purchasing Controls.
- Implemented Final Release procedures, forms and retrospective evaluation of distributed product and prevented a probable injunction by FDA.
- Implemented Medical Device Reporting procedure and performed assessments on existing complaints resulting in zero 483 Observations against 21 CFR Part 803 Medical Device Reporting.
- Prepared complete response to FDA Form 483 Observations for the client.
Professional Experience
Independent Consultant 2010 - Present
Quality Systems consulting company serving the Medical Device, Pharmaceutical, & Biologics industries
President/Member
- Guided 6-project teams through the Design Control Process, for contact lens and lens care products, at a global contact lens and lens care solution manufacturer. Project types include:
- Active member of several Global Change Review Boards and Change Implementation Teams at two large companies. One in an Advanced Molecular Imaging, capital equipment company and the other for contact lens care. (U.S., Canada, China and Israel)
- Managed subcontract regulatory consulting work to write and submit the 510(k) for a Health Assessment Kiosk.
- Planned Phase-2 development of the software driven Health and Wellness Kiosk. Accomplishments include:
- 2-Fashion wear contact lens designs
- 2-H2O2 lens care systems (Complying with different regulations in different countries. These are medical devices in some countries & pharmaceuticals in others.)
- 2-Contact lens designs for prophylactic myopia treatments, in Asian specific optic anatomies
- Drove complete re-write of the Health Assessment Kiosk Risk Analysis, considering potential
- Product component failure modes
- Software functional failure modes
- User Requirements
- Design Requirements
- User Interface malfunctions
- ISO 14971 Annex-C considerations
- Clarified documentation of requirements for User Interface/Touchscreen facilitating the following:
- Visual acuity testing
- Body Mass Index measurement/calculation
- Blood pressure measurement
- Storage/retrieval of historical data in user created account
- Selection of, and appointment set-up with, local doctors, based on assessment
- Advisor during hiring process for subcontract consultants to work, including writing contract letters to obtain Canadian Work Permits for each member of the consulting team.
- Wrote multiple project plans to qualify Contract Manufacturers/Third Party Organizations (TPOs) to produce 30+ SKUs for OTC pharmaceuticals; and for contract renewal remediating APQRs, Complaints, Stability Testing and Quality Agreements, according to 21 CFR Parts 210 & 211.
- Assigned delegate quality consultants on multiple projects and worked directly on the following projects:
- Overseeing quality systems remediation at Contract Manufacturers prior to manufacturing operations and establishing Quality Agreements, including one for a Canadian facility extending to their sub tier manufacturing/packaging facility, according to both Health Canada and U.S. FDA requirements.
- Remediation of backlogs on Complaints, APQRs, CAPAs and Change Controls.
- Organizing and coordinating initiation of Follow-up Stability Testing.
- Established a Manufacturing Transfer Checklist template for transferring processes into multiple TPOs.
- Drove Medical Safety Team Software User Requirements Specifications (URS) for the TrackWise upgrade.
- Prioritized URS requirements with Sparta Systems & independent TrackWise programmers.
- Drafted 1/3rd of the OQs & PQs for the software validation.
- Participated in “Dry Runs” of the upgraded software in the prototype environment.
- Executed OQs & PQs authored by other software validation team members.
- Completely re-designed and implemented a Risk Management process, tying customer requirements with all quality system and manufacturing processes into 1-Risk Management File. As a contract manufacturer, the system was challenged through lack of design information from customers, to provide product related risks. The new system tracks risks through all processes, for all product lines, regardless of customer served. Built-in feedback systems automatically driving continual updates of the Risk Management File.
- Completed Installation Qualifications (IQs) on 14-machines on the manufacturing floor.
- Characterized the process for 4-vertical milling centers.
- Designed Experimental Test strategy for Operational Qualification (OQs) of the 4-vertical milling centers, establishing worst-case factors and extreme operating parameters.
- Established insurance at $1MM for Errors & Omissions, and $2MM aggregate for General Liability.
- Achieved ASQ Certified Biomedical Auditor and ISO 13485:2016 Lead Auditor Certification.
NOVALIGN ORTHOPAEDICS, INC., MEMPHIS, TN 2009 - 2010
Orthopedic startup, manufacturing intramedullary nail implants
Senior Manager of Quality (employee # 8)
- Drove implementation of entire quality system & operations.
- Production & assembly facility
- Warehouses for finished goods, components, instruments & accessories
- Inventory management procedures
- Procurement systems and initial material ordering systems
- Shipping and distribution models and systems
- Audit management (Also performed audits in Germany, Switzerland, France, England and Puerto Rico, - managed audits done in China, Taiwan & Japan)
- Initial approval of suppliers
- Control of Approved Supplier List
MEDTRONIC SPINAL AND BIOLOGICS, MEMPHIS, TN 2005 - 2009
Manufacturer of spinal implants
Supplier Quality Manager 2006 - 2009
- Implemented division-wide, centralized Supplier Quality Program, using a Risk Burn Down process for categorizing and prioritizing suppliers. Also staffed the new Division Level Supplier Quality department.
- Developed a process for managing outsourced OEM products, linked with Design Controls. Included special requirements for OEM components, requiring evaluation of interfaces with “own branded” products.
- Completed a 10-month management course (BAMM – Becoming a Medtronic Manager) modeled after the IBM Blue program. Course included:
- Planned & negotiated supplier quality integration after acquisition of the Kyphon business.
- Green Belt Trained in Six Sigma & Lean Sigma techniques. (This was separate training from the BAMM program.)
- Acted as Senior Manager of Design Quality Engineering during his 3-month absence.
- Ethics & compliance
- Talent management & retention
- Team building
- Stakeholder Analyses
- Effective communication
- Problem solving techniques
- Conflict management
- Methods of giving effective feedback
- Decision making
- Lean & Six Sigma principles
- Talent development
- Case studies
MEDTRONIC SPINAL AND BIOLOGICS 2005 – 2009
Lead Quality Engineer 2005 - 2006
- Achieved division-wide agreement on a centrally controlled Supplier Quality System, answering FDA questions on PMA & HDE submissions, and eliminating 15-plant specific work instructions.
- Corporate Quality Engineering team representative for the Horseheads plant:
SYNTHES USA, HORSEHEADS, NY 2003 - 2005
Manufacturer of orthopedic implants
Sr. Quality Engineer 2004 - 2005
- Coordinated all gages procured for new products and delegated amongst 4-Quality Engineers
- Evaluated and piloted Inspection Reduction Software. Took lead evaluating CAQ inspection software as sole German speaking team member. Evaluated CAQ software demo available only in German.
- Global Harmonization of Gages, evaluating techniques in Switzerland to incorporate at US sites
(Harmonization needed after Synthes merger and acquisition of two European companies.)
Quality Engineer 2003 - 2004
NOVOSTE CORPORATION, Norcross, GA 1998-2003
Manufacturer of vascular brachytherapy systems (Beta radiation delivery system to treat in-stent restenosis of the coronary arteries)
Project Engineer 2000-2003
Senior Engineer 1998-2000
GENZYME SURGICAL PRODUCTS, Tucker, GA 1996 – 1998
Manufacturer of surgical hand instruments, endoscopic instruments, video cameras, sutures, insufflators and surgical instrument cleaners & lubricants
Quality Engineer
- Supervised 2-direct reports for complaint investigation and repair of insufflators, cameras & scopes.
- Led several teams implementing systems that gained ISO 9001 & EN 46001 certification.
- Direct contact for FDA inspections successfully defending FDA allegations for numerous Medical Device Reports (MDRs) not submitted. Result: prevented regulatory action from FDA and need for future reports estimated at 120.
C.R. BARD, BARD UROLOGICAL DIVISION, Covington, Georgia 1993 – 1996
Manufacturer of urological catheters, ureteral stents, collagen injection devices to treat incontinence, biopsy needles, gynecological smoke evacuators
Plant Quality Engineer
- Investigated and closed all complaints submitted against all products produced in the Covington Plant for C. R. Bard’s Urological, Gynecology/Radiology, Patient Care and Medical divisions
- Supervised 2-direct reports responsible for roving plant floor inspections, complaint investigation and release of serviced & repaired Urotrack Monitors™ and Biopty™ Guns.
- Developed repair trending system for the electronic Urotrack Monitor™ and Biopty™ Gun equipment
BRASSELER USA & KOMET MEDICAL, Savannah, GA 1990 – 1993
Manufacturer of rotary dental and surgical instruments (carbide, stainless steel & diamond burs) and surgical saw blades
Technical Director
- Supervised 7-direct reports, 1-technician and 6-QC inspectors.
- Direct contact for, and handled one audit each, for FDA, EPA & OSHA investigations.
ROCHESTER OPTICAL MANUFACTURING COMPANY, Rochester, NY 1989 – 1990
Manufacturer of eyeglass frames (military contracts and designer sunglasses)
Manufacturing Engineer
- Supervised 1-direct report responsible for production equipment maintenance and repair.
- Implemented several production lines for the standard military eyeglass frames.
- Implemented a new lens edging production line for the new designer sunglass line.
CALDWELL MANUFACTURING COMPANY, Rochester, NY 1984 – 1989
Manufacturer of window hardware and counterbalances for double hung windows
Design Engineer
- Named on 3-patents, one resulting in a $750,000 out-of-court settlement with a competitor.
- Re-engineered 2-year old product with negative revenue and turned it into a $5,000,000/year product.
Education
Rochester Institute of Technology, Rochester, NY 1982 – 1986
Bachelor of Technology in Mechanical Engineering
State University of New York (SUNY) at Morrisville, Morrisville, NY 1980 – 1982
Associates in Applied Science in Mechanical Engineering
- Dean’s List in 1st and 4th semesters
- NJCAA Wrestling Team, Freshman year
Certifications
MD – Medical Devices Quality Management Systems ISO 13485:2016 – BSI Certificate # 8925972/134669-191441
TL – Leading Management Systems Audit Teams (ISO 19011:2011) – BSI Certificate # 8925972/134674-191441
ISO 13485:2016 Lead Auditor (TPECS) – BSI Certificate # 8925972-191441