Benjamin K. Email & Phone Number

Full service definition and leadership of new Quality management system in preparation for initial ISO13485 MDSAP certification, and FDA pre-approval inspection to 21CFR820. Quality engineering support for new product development, risk management (to ISO14971), and verification of product compliance to applicable standards in Design History File (DHF)..

Switzerland 🇨🇭, CH

-Negotiate process integration from acquired company (GenMark Diagnostics) in supplier quality, supply chain management and audit program currently in force with Roche global standard practices and modular QMS system. -Write new procedures, develop process flows and mentor/train others in best practices in quality audits, purchasing controls, and.

Develop and execute quality plan to:1. Gap assess entire quality system for compliance to 21CFR820, ISO13485:2016 and ISO14971: 2019 while preserving and enhancing processes related to combination device clinical trial management and biologics GMPs per 21CFR210/211 and part 600. 2. When the gaps are agreed to, revise all procedures to address all gaps with.

New Brunswick, NJ, US

Help to anticipate and mitigate operational and quality system risk for client (J and J hospital and medical technologies division-HMT) by evaluating compliance and gaps to compliance to Swiss Medical Device Ordinance, and EAEU (Eurasian Economic Union). This work utilized the assessed gaps to drive changes in the various layers of quality systems within.

San Francisco, CA, US

Assist client company evaluate its quality management system for compliance to ISO13485:2016, FDA 21CFRPart820, and EU-IVDR. Complete Gap Assessment-then evaluate options with client stakeholders to deploy improvements within the organization and then develop the plan to bridge the gap. Per the plan1. Developed procedures2. Revised workflows3. Revised.

San Diego, California, US

As a knowledgeable practitioner that has operated under several bodies of medical device law (different countries) and their practical implementation in business and personal R&D experience in drug formulation and materials engineering, I have completed a role at TriLink Biotechnologies, an innovative contract manufacturer poised for tremendous growth.

Assist company to address backlogged CAPA projects by partnering with internal stakeholders to develop appropriate solutions. Responsible for team meeting facilitation, root cause analysis training and facilitation, documentation within the CAPA, and guidance of team members. Assess health of the quality system through audits and recommend changes and.

San Diego, California, US

Select key suppliers to assist Dexcom its business transformation.Audit/develop critical suppliers to a variety of different standards and laws depending on the scope of work. This includes ISO13485, ISO17025, 21CFR820 for quality management systems, and multiple other standards depending on the specific type of services and/or goods (i.e. ISO10993, ISO.

Abbott Park, Illinois, US

• Accomplishments:
• Assisted client with coordination of CAPA system resources to provide a seamless solution to address a large backlog of CAPAs.
• Gave direction on how to apply Abbott CAPA policies and procedures.
• Developed guidance on how to address non-standard situations such as criteria and justification for CAPAs that were opened but only needed correction, and not corrective action (i.e. software patches).
• Trained other engineers in investigation techniques, methods of documentation, and the development of a logical narrative intended to convey complex information in the most effective way.
• The team helped CAPA owners move 50 late CAPAs forward Responsibilities:

Los Angeles, California, US

1. Lead the Quality Management system through a time of significant change.2. Upgrade the QMS to comply with ISO13485:2016, MDSAP, and MDR in Europe.3. Develop and maintain operational metrics and data collection systems.4. Manage quality resources.5. Modernize elements of the QMS to reduce effort and maximize resource allocation. 6. Host 3rd party.

• Lead team to develop and prepare for first FDA inspection. Also lead FDA mock audits.
• Developed internal audit program and lead several internal audits,
• Developed the supplier quality assurance program and trained others to run it.
• Developed company CAPA system, non-conformance system and updated all other quality systems to ready company for commercial operation.
• Deployed "lean" manufacturing and quality principles, in processes and procedures using appropriate service and performance metrics
• Evaluated the Design History File for gaps to relevant standards and to design risks (using processes defined in ISO14971) to help the team improve the likelihood of a successful Pre-Market Approval submission on a.

Brea, California, US

• Lead projects on the transition of IRIS International into the Beckman Coulter Quality System.
• Developed and executed plans for the remediation of the CAPA system, Design controls, and process validation. Also included work to integrate complaint handling system with the CAPA system, and other changes.
• CAPA age reduced by 60% (mean age was greater than one year).
• Unresolved process deviations reduced by 90%.
• Supported the execution of major design changes and continually updated risk management files as needed while ensuring that overall design controls were being followed at the plant.

Forchheim, DE

• Formal management and leadership: Quality leadership and management representative over three Siemens’ physical sites and lead Quality Management team-8 employees. Successful guidance/leadership for several ISO 13485.
• Guided plant quality management practices during a time of significant change to global Siemens management system policies and business culture.
• To ensure effective implementation of these policies, I coordinated teams to modify and improve the performance of business systems including the local Quality Management System.
• Program Team Leadership: Division level Quality System support in response to warning letter- CAPA system, Process validation practices, and design controls systems retooled from the ground up using multiple site best.
• Sites worked under 21CFR 820, ISO13485, CMDCAS, Japan Ordinance 169 and overall JPAL, European IVDD.
• Developed/maintained plant level performance and service metrics: Reduced design change project turnaround times by 50%, change order turnaround time by 30%, non-conformity deposition by 80%, etc. As a result, more.

Fridley, Minnesota, US

• Improved Manufacturing Processes: Improved process results using formal techniques (i.e. DMAIC) for drug delivery device subassembly-reduced scrap rates by 20%; improved throughput by 10%. Improved yield on Elanco.
• Coordinated plant Internal Audit Program. Improved non-conformance response rate by 50%, improved effectiveness rate from 75% to 90%, drove multiple audit methods-process, system, and element audits.
• Project Leadership: Coordinated Corrective and Preventative Action Program. Converted Plant CAPA system form a paper based system into electronic only system. Improved process flow and enhanced training program. Result.
• Helped to design a plant training program, constructed training in QA and Operational Excellence tools and industry regulations, and implemented classroom instruction. Over 100 employees were trained, and passed their.

• Improved Manufacturing Process: Used data from SDS-PAGE, HPLC (RP and SEC) FTIR, Malvern Particle size and Zeta potential measurement for evaluation of novel protein-based dispersions to drive improvements to critical.
• Defined a reference materials control program to reduce lot-to-lot performance drift of these materials. Reduced scrap rate of non-conforming lots by 50% (10% to 5% rate) resulting in a savings in excess of $300K per.
• Supported team by analyzing data and by designing effective and inexpensive experiments to solve yield, activity and concentration variability for Flu antigen, Strep A antigen and antibody functionalized dispersions.
• Coordinating a team of scientists, and line manufacturing staff; improved the capability of key manufacturing processes (protein conjugates) reducing rate of failure from 15% on average to less than 1%.

• Lead Material qualification activities for components directly used in the design of a Class III implantable medical device (Drug Eluting Stent) and concurrently supervised the analytical lab. Wrote portions of CMC.
• Assistant in the design of the drug formulation used on the drug eluting stent. Developed rate release models, physico-chemical models to define product design controls, etc.
• As a Technical QC Lab Leader (Title-Senior Chemist) I was responsible for the work of 11 people and improved internal service quality by reduction of turn-around time by 30% and error reduction by 50% through a.
• Conducted supplier development activities to reduce impurities and improve material processing ability (i.e. melt range, viscosity, mixing efficiency, etc.) through chemical analysis and correlation to processing.
• Improved raw material flow logistics: shipping and handling, storage controls leading to reduction of scrap by 40%.
• Participated in designing supply contracts with material vendors while concurrently reducing technical and quality assurance risks for excipient polymers at vendor site.

• Lead team of employees to support various medicinal R&D teams in reaction development and drug-lead optimization.
• Lead research, development and method optimization for high throughput analytical methodology using LC-MS-ELSD, LC-MS-MS, SFC-MS-ELSD, HPLC, FTIR, NMR (H and C) and other techniques. Wrote protocols and participated in.
• Consultant on novel chemical analysis needs. Conducted stability tests in-vitro of drug candidates.

Mba, Business Operations

Bachelor’S Degree, Chemistry