Overall readiness assessment of Medical Device manufacturing organization to move from COVID-19 IVD screening products under EUA to 510(k) status. Senior Quality Assurance resource for performing organizational and manufacturing Gap Assessments, as well as management consultant and operations training.

Operational on-floor support quality engineering for Pharmaceutical, Biotech, and Gene Therapy components and products for remediation, review, and approvals, including batch records, LIMS, MODA, MES, PLOGS, PDOCS, and AMPS systems and processes. Developing new event (deviation) processes by researching and enhancing risk processes, product impact, and process savings, and by working cross-functionally with Manufacturing, QA, and Microbiology to overcome chronic compliance holes.

Cross-functional Quality & Technical File resource for updating client’s product lines from MDD to MDR. Developed relevant technical documentation (Risk Management, GSPR, PSUR, CER, DMR, Design Changes, Design Reviews, etc.) and oversaw proper completion of Quality Technical Files from various interdepartmental teams for submission to Regulatory using Best Practices.

EU MDR expert overseeing the building of various GSPRs for the company’s Class III product lines. Heading up cross-functional risk management teams, including the development of risk management documentation through working meetings with medical experts globally.

EU MDR expert redesigning processes and systems, assessing and redeveloping Risk Mgt files for combination products (Class IIa device and drug), leading the technical team working with cross-functional resources to finalize Quality documentation, and subject matter expert on developing entire EU MDR Standard Technical File and Quality Management System organization for both Medical Device and Pharmaceutical from scratch using current Best Industry Practices. Lead Auditor for Supplier Quality Audits and internal training of resources for supplier audits.

EU MDR expert redesigning Quality Management operational processes and systems, assessing and redeveloping Risk Mgt Files for various Class I & II devices, part of the technical team working with cross-functional resources to finalize Regulatory documentation, subject matter expert on developing the entire EU MDR Standard Technical File from scratch, and developing risk management documentation through working meetings with medical experts globally.

Sole expert resource crafting company’s Quality and Design Control Systems for new facility manufacturing Class I blood vacutainers, using newly established automated and continuous processes within Class 100,000 clean rooms, training and teaching teams of validation engineers to execute their work in aseptic environments for formulating and filling. Lead the team on building facilities, building codes, cleanroom requirements, capital expenditures, and resourcing.

Chief architect of the facility’s Quality Management System and Cleanroom/Building construction, including validation and qualification developing and documenting cleanroom spaces, LAFWs, Isolator Hoods, sterile fill processes, procedures development, equipment use, and biological products to meet FDA and State of Florida’s regulatory requirements for a 503B outsourcing facility. Performed verification and validation of automated filling equipment using PLC technology, qualifying aseptic Class 5 & 7 clean rooms for formulation, filling of sterile injectable liquids, developing prefilled syringe products, and generating batch records from scratch. Constructed and qualified negative pressure cleanroom using a large LAFW, and developed efficient SOPs, process flows, operator training, and batch records for hazardous chemicals/biologics. Developed all the Risk Management documentation for the site, as well as the drug files, sterilization validations, and equipment validations required for FDA and Board of Pharmacy auditing.

Hired to oversee strategy for closing legacy and newly opened CAPAs for a domestic division of an international infusion pump manufacturing company, utilizing Lean practices to streamline production processes, combine production records, reduce redundancies, and save processing time through a complete review of necessary processes, quality control inefficiencies, and product approvals.

Single senior resource directly supporting the Department Head and junior PM overseeing, strategy, resources, budget, and logistics of bringing hundreds of thousands of product SKUs into EU MDR compliance ahead of the May 2020 deadline by leading an international cross-functional team of R&D Engineering, Sales, Supplier Quality, Executive Management, and other consultants.

R&D single resource consultant bringing a Sales-driven balloon catheter project out of mothballs, liaison to the Contract Manufacturing Organization located in Minneapolis, MN, and driving generating a completed STED Technical File from scratch in 10 months, as well as developing Quality and Manufacturing Agreements for clients. Solely responsible for generating all Risk Management, Design, DMR, Specifications, Changes, Manufacturing processes, DMR, DHF, and Design Review files.

Single resource project lead managing the transition of paper-based medical device’s Quality Department to a fully realized and validated Pilgrim Quality Solutions’ SmartSolve system, Complaints Module. Interfacing directly with Pilgrim’s technical development personnel, I lead the team to help the program to include an updated version of current Good Manufacturing Practices and Quality needs through a program of good risk analysis, Voice of the Customer, and Human Factors.

Single resource team lead tasked with managing and closing 14 Distribution Centers’ Corrective and Preventative Action Plans (CPAPs), closing 60% of open CAPAs within 30 days through an exercise of QMS documentation review and experience in closing risk stratified and redefined CAPAs.

The Quality Engineer leading a team of three junior consultants to inventory, assess, and validate anodizing and metal fabrication processes transfers to new plant plus documenting process characterizations. Produced documentation supporting qualifying large anodizing operations before the process transferred to another facility as well as generating a full process characterization report that included process flows, pFMEAs, equipment qualifications, time and motion studies, supply chain dynamics, and purified water needs.

Single resource lead auditor performing a comprehensive investigation into all company processes. When completed, the company requested consultant services to remediate a broad base of process improvements, as well as compliance and policy corrections including changes to CAPA, Complaints, Sustaining Engineering, Manufacturing Processes, Supplier Quality, Quality Management, and Internal Audits

Single resource Quality Engineer developing a Device History File for a legacy IVDD that had been on the market for over 18 years, per FDA Form-483 observations. Performed comprehensive investigation and research into fully paper-based historical files to create a successful electronic DHF in 8 months. Completed a sustainable and defendable DHF in record time, allowing multi-million-dollar revenue-generating operations to continue without interruption.

Managed a downstream of 13 quality individuals and managers, supporting all biologic fractioning manufacturing processes and product. Introduced novel quality training sessions to draw in cross-functional personnel across all departments to support manufacturing, lead a process of improving batch record approvals through a program of mentoring junior support personnel, and trained different department personnel in how to use functional relational databases to manage work orders, equipment calibrations, supplier quality scorecards, and project tasks. Part of the Task Force implementing multimillion-dollar capital building expense, introduction of new equipment and processes, and qualifying/validating processes for use.

End-to-end single resource PM of international Corrections & Removals department for a major multimillion dollar diagnostic medical device manufacturer while under a division-wide Consent Decree. Developed a system by which Risk Management (HHA) could be scientifically calculated and probabilities established to better document risk in language the FDA could understand, giving Regulatory ample defendable evidence for closing over 80% of company’s outstanding CAPAs and Complaints.

Single resource Quality Engineer working with Supply Quality department head to develop and generate a complete and comprehensive QMS including Supplier Qualifications, Supplier Scorecards, Quality Agreements, Manufacturing Agreements, generating all SOPs, Receiving Inspection statistical rationale, Test Method Validation, developing and issuing SCARS, and training personnel on inspection criteria.

Hired to lead team of consultants to assess equipment qualifications, documentation accuracy, and overall cGMP compliance. Developed scorecards for communicating Data Analytics for newly acquired facilities. Investigated all areas of QMS compliance; presented findings to project manager for final assessments.

Compliance quality Engineer team member assigned to perform data analytics on existing open CAPAs throughout the international organization. This effort was spearheaded to define open CAPA issues, reasons for timeline delays, strategize logistics, and create definitive teams and plans for closing CAPAs across the board working with Department Heads, Engineers, Quality and Regulatory. Effort managed to bring down Days to Close more than 300%.

As part of the executive management team, built an experienced core management team, locate a manufacturing site, apply for licenses, and develop product lines and strategies for bringing products to market on a limited $3 million budget. Building up a team of 15 direct reports, and established a functional manufacturing team capable of producing OTC pain relief products and prefilled syringes that would have netted the company a minimum of over $5 million revenues the first year in existence.

Department Head overseeing Quality operations, including hoods qualification and calibration; Quality Management Systems development from scratch, quality records development, batch records development, KPIs development, training all levels of personnel including executive management of Code of Federal Regulations, quality systems and processes. Developed didactic training for laboratory personnel and completed standard operating procedures for all departments.

Department Head advising executive management on regulations for manufacturing and distributing Homeopathic drugs while establishing a total QMS aligned with FDA regulations and CMC operations. As a startup organization, designed processes, procedures, and documentation control systems in compliance with regulatory and quality standards from scratch. As a direct result of my research, the company was legally able to develop a new drug product, get it released into the market through the Homeopathic regulatory pathway, and realized over $5 million worth of sales of Cobroxin to Walgreens, Rite-Aid, Duane Reed, and other national drug chains domestically in the first year. Also responsible for developing equipment qualifications, sterile fill process validations using LAFW and isolator hoods, company equipment lists and managing calibrations schedule.

Team Lead of four engineers, tasked with a complete and comprehensive investigation into all equipment and processes in corporate’s Tecate, MX facility. Because of a well-organized effort, team managed to completely qualify the entire facility in six months, well ahead of schedule set by corporate as a target.

Team Lead Engineer leading DHF investigations, CAPA investigations, process validation, protocols and execution, equipment qualification protocols, IQ, OQ, PQ development, statistical sampling development, and generating Final Reports to qualify efforts to transfer major processes from Santa Anna, TX and Puerto Rico to Juarez, MX.

Single resource part of a major effort by a multimillion-dollar division in Doral, FL (Project Horizon) to assess all Technical File documentation on every acquisition product line purchased by corporate, develop gap assessments, and perform all process and product validations over the course of 5 months.

Department Head, hired to support executive management with the development of a total QMS, supporting the growth of a $200K/year profit business to over $2 million a year by implementing Lean philosophy, driving an increase of production throughout over 300% implementing processes that lowered process times by over 200%, and moving cassette injection molding process to the U.S. thereby reducing component lead times by over 250%.

Built an international service, repair and maintenance department in compliance with 21 CFR 820, Part N, ultimately internationally installing and uninstalling 22 of the world’s first laser-based breast scanning diagnostic equipment designed to image blood and definitively identify the presence of breast cancer in patients. Worked with Engineering to develop the company’s first dFMEA and pFMEA.

Lead Quality Engineer on the Leads manufacturing line for a cardiac pacemaker company under Consent Decree. Rebuilt the entire manufacturing line’s SOPs, drawings, exploded diagrams, and processing forms, as well as revalidated the lead materials through vigorous machine testing to prove the capability and reliability of the product to the FDA.

As an R&D engineering tech, I was to support the development of raw materials supply, installation of manufacturing equipment, qualifying floor equipment, perform process efficiencies and capabilities through the use of Six Sigma statistical tools. Developed an entire balloon angioplasty catheter manufacturing line through validation and transfer to manufacturing.