Michael B. Vader, M.S., RAC
“I had the pleasure of working with Michael for the last 6 months at MD Orthopaedics. Michael was tasked with taking the lead in cleaning up our regulatory, quality, and engineering departments. Michael's knowledge, attention to detail, and his ability to encourage and teach the members of our team allowed us to make great strides in getting where we need to be. Michael has the unique ability to guide team members under his watch to complete tasks that they didn't think possible. As an example, under his leadership I was not only able to completely rewrite our Design and Development process but I was able to understand what was needed to complete the job. This example would not have been possible without his guidance. I highly recommend Michael and his vast knowledge of both regulatory and quality systems for any opportunity that you may have available for him. Michael left the team at MDO encouraged with the knowledge and ability to work through regulatory and quality issues as we move forward. Michael will be greatly missed as a mentor”
Marcus Powell
Senior CAD Design Engineer/Tool Maker
OrthoPediatrics Corp. (Formerly: MD Orthopaedics, Inc.)
"I've had the pleasure of working with Michael for the 5 months he was hired as a Quality Assurance Manager at Vical, Inc. Michael jumped right in and managed his interactions with team members at all levels effectively. He understood the needs of the company and was able to provide the required support. It was a pleasure working with him"
Thomas Hilgert
Associate II, Research
Brickell Biotech, Inc. (Formerly: Vical Incorporated)
"Michael's vast knowledge and expertise coupled with his organizational skills and outside the box thinking made him a trusted and valuable member of our organization. He is also very personable and a pleasure to work with."
Brandi Barkley
Operations Coordinator
Abbott, Inc. - Global Business Unit (Formerly: Alere North America, Inc., Inverness Medical, Inc., Biosite Diagnostics, Inc., Innovacon, Inc.)
“Michael is a meticulous quality recourse who brings years of knowledge and dedication to every project he tackles. I've had the pleasure to work with Michael on two projects and can say with absolute confidence that he will be a valued addition to ANY team.”
Steven Crabtree
Project Manager, Quality Engineering
Philips, Inc. (Formerly: Spectranetics)
“Michael is a great colleague to work with. Produces good quality work in a timely manner and always with a smile. It was a true pleasure working with Michael and I would gladly recommend him as a tremendous asset to the right organization!”
Hiren Patel
MedTech QA SME
Philips, Inc. (Formerly: Spectranetics, Inc.)
“Michael has been a consultant of ALKU's for several years and I have had the pleasure of being his recruiter. It is very hard to come by someone that stays loyal to his recruiting company and he did just that. Michael has been working on the same project for us for the past 4 years and received excellent reviews. He hit his deadlines on time and exceeded expectations all while keeping a positive attitude in a hectic environment. Michael would be an asset to any employer and I recommend him for any endeavor he chooses to pursue.”
Brittany Youlden
Professional Recruiter
ALKU, Inc.
"Michael is thorough, detail oriented, innovative and a highly driven individual. These traits in addition to his dedication, leadership abilities and vast knowledge of the industry made him an invaluable team member!”
Lonny Hendrickson
Manager, Warehousing and Service Excellence
Abbott, Inc. - Global Business Unit (Formerly: Alere North America, Inc., Inverness Medical, Inc., Biosite Diagnostics, Inc., Innovacon, Inc.)
“Michael was assigned the challenging position of implementing and managing the Quality Management System during the merger of companies and the combining of multiple facilities under one QMS. He was successful by learning cross-functional processes, developing relationships, documenting processes and diligent follow-up. He is a self-starter who requires little direct guidance. Given the opportunity I would gladly work with Michael again.”
David Kuszmaul
Director Quality Assurance
Abbott, Inc. - Global Business Unit (Formerly: Alere North America, Inc., Inverness Medical, Inc., Biosite Diagnostics, Inc., Innovacon, Inc.)
“It was really a delight working with Michael at Philips. We worked together on a FDA remediation project with very tight timelines. Michael quickly proved to be a subject matter expert on Validation and Regulatory Affairs. I can highly recommend Michael for any quality, validation, and regulatory affairs position in the medical device field where his expertise along with his years of direct medical device experience will make him a valuable contributor.”
Anil Pant
QMS Validation, Regulatory, EU MDR Consultant
Philips, Inc. (Formerly: Spectranetics, Inc.)
“Michael is detail oriented and genuine. He is a fast learner and very motivated to succeed at whatever he is doing. He has a strong grasp of regulatory affairs and I believe I learned more from him than he did from me! He is not only concerned with the success of the company, but of the individuals around him. I know he will excel in whatever challenge is laid before him.”
Michael B. Anderson
Director of Regulatory and Clinical Affairs
Ortho Development Corporation.
“I had the privilege of working with Michael. Michael is very proactive, detail oriented, responsible and technically sound employee and he is always ready to put all his energy and time to get the job done. He sees and can address everything from the bug picture to the details. Michael is highly motivated with great communication skills. He is an asset to any company that he's with. He has a very impressive background and profile and I recommend Michael as a expert to connect with. Additionally, Michael has done a series of small favors for me in the process, showing his sincerity and generosity. On that basis, I want to highlight Michael for being there for me when I have needed him.”
Divya Palan
Regulatory Affairs Specialist
Ortho Development Corporation.
"Michael is skilled at quickly assessing the needs of an organization, developing a strategic vision and establishing systems and processes that take the organization to the next level of success. As an executive leader, Michael combines in-depth knowledge, goal driven leadership and cutting edge innovative technologies to increase efficiency and achieve regulatory compliance."
Arthur Simental
Manager, Quality Systems
Absolute-DSI (Formerly: Diligent Solutions, Inc., Formerly DBA: Absolute-EDM)
“Michael is a leader that executes through performance management and value-driven metrics. As a former colleague and ongoing consultant contract business partner, I find it to be a privilege to work with Michael on project teams. I know his work ethic and deep knowledge of regulatory affairs and quality assurance will be instrumental in setting the course for the projects and meeting all of the requirements. I rarely come across someone like Michael who has such a vast amount of experience in a multitude of business channels.”
Cathena Cyr
Supply Chain Manager
Breg, Inc.
“Michael is one of the most thorough, reliable and dependable Quality professionals that I have worked with. He is knowledgeable, enthusiastic, always willing to go the distance and he always meets schedules and deliverables. I am glad to have had the opportunity to work with him.”
Roland Bessette
Quality Assurance Manager-Electronic Document Control System Administrator
Abbott, Inc. - Global Business Unit (Formerly: Alere North America, Inc., Inverness Medical, Inc., Biosite Diagnostics, Inc., Innovacon, Inc.)
"To whom it may concern, I would like to offer a formal recommendation for Michael Vader. As a way of introduction, I have been in the regulatory affairs field for three years, and graduated from San Diego State University with a Bachelor’s of Science in Biology. In my short time in the regulatory field I have worked my way up to regulatory affairs specialist II in Abbott’s toxicology business unit. In my time at Abbott, I have been the main point of contact for any customer facing labeling requests for our immunoassays. I met Michael Vader in September of 2019 when he was brought on to the regulatory affairs team as a regulatory affairs manager for Abbott’s toxicology business. Michael was brought on to help support the sustaining regulatory activities for multiple business units associated with the toxicology business. During this time we would work collaboratively when sustaining projects required new labeling. Michael helped me in understanding regulations and compliance, which greatly excelled my own career. Michael always took the time to explain and answer any questions I had. During the last project we worked on together, for an accessory device to a drugs of abuse screening system, Michael was the lead regulatory affairs personnel, while I was supporting the labeling aspect. For labeling inputs, I would consult Michael, who would either be able to assist me, or knew who the correct point of contact would be. When it came time to approve my labeling items, Michael would quickly and thoroughly assess all documents to ensure all claims were supported by our verification reports. Thanks to his eagerness to help, and his haste to complete the approvals, it allowed me to complete all of my deliverables for the project ahead of schedule. I believe Michael would be a valued member of any team, as he holds a vast knowledge of regulatory compliance, and is eager to help others understand it as well."
Michael O'Sullivan
Regulatory Affairs Specialist II
Abbott Rapid Diagnostics (ARDx), Inc. (Toxicology Business Unit: Ameditech, Inc., eScreen, Inc., and Immunalysis, Inc.)
“Michael is a great mentor. He challenged me to learn new things, encouraged me to press on whenever I became overwhelmed, and praised my triumphs.”
Shawn Twyman
Design Engineer
OrthoPediatrics Corp. (Formerly: MD Orthopaedics, Inc.)
“Michael has been a great leader. He is a detail-oriented & objective-driven individual that can help the team set clear goals and improve the working process to get things done efficiently & quickly. Michael is very knowledgeable at QA/RA. Working with a diligent and visionary leader like him has been a complete pleasure.”
Luxi “Luke” Li
Consultant, Regulatory Affairs and Quality Assurance / Electrical Engineer
Colfax Corporation. (Formerly: DJO Global, Inc.)
“I have worked closely with Michael for the last 6 months while he was my direct superior over Quality/Regulatory. Michael excelled in his role, exhibiting a refined amount of knowledge of Quality, Regulatory, Risk Management, Engineering, etc. Not only did Michael have a great amount of knowledge, he was willing to educate and help anyone who expressed interest in what he knew. Michael possesses a high volume in confidence in his work and knowledge. He is a very transparent person who has a very upbeat personality. Working with and for Michael was easy as he is incredibly encouraging and empowers all those around him. I volunteered to write this recommendation for Michael because I am very grateful for his contribution to the Quality, Regulatory & Engineering departments at MD Orthopaedics and extremely confident in his intelligence, work ethic, communication skills, and determination to add value in any company."
Heather Tyler
Senior Quality Assurance Specialist
OrthoPediatrics Corp. (Formerly: MD Orthopaedics, Inc.)
“I have worked with Michael on Process (PFMEA) remediation projects at DePuy Synthes. He has great project resolving acumen. Michael brings a solid regulatory understanding to projects and knows how to balance the regulations, business needs and customer needs. Personally, I enjoy Michael's out of the box thinking when problem solving challenging situations."
Christian Mbanefo, BS, MS
Subject Matter Expert (SME), Quality Assurance and Risk Management
Johnson and Johnson, Inc. (Formerly: DePuy Synthes)
"In all my years in manufacturing I can honestly say that I have never worked with a person as talented and educated as Michael. He is the type of person that can elevate the quality and performance of a company. He is a great leader not only by leading but by allowing others to lead, that is a true leader. I would recommend Michael to anyone in any industry."
Alexander Luna
Supervisor, Quality Control and Manufacturing
Absolute-DSI (Formerly: Diligent Solutions, Inc., Formerly DBA: Absolute-EDM)
"I’ve had the pleasure of working with Michael for the past 4 years at Alere, Inc. His business acumen and professional services focus has empowered him to solve complex business problems as a true leader. Michael is a tremendous talent with excellent subject knowledge and gets along extremely well with colleagues and stakeholders at any level. I believe that Michael would be an invaluable addition to any organization.”
Joe Johnson
Manager, Distribution Operations
Abbott, Inc. - Global Business Unit (Formerly: Alere North America, Inc., Inverness Medical, Inc., Biosite Diagnostics, Inc., Innovacon, Inc.)
"Besides being a joy to work with, Michael is a take-charge person who is able to present definite ideas and communicate the benefits. He is very consistent, tackling all assignments with dedication and a smile. He has been a great team player and mentor to me."
Snigdha Katragadda
Consultant, Regulatory Affairs and Quality Assurance / Biomedical and Electrical Engineer
Colfax Corporation. (Formerly: DJO Global, Inc.)
“Michael and I worked together as members of a Technical File Remediation team and DePuy Synthes, Johnson and Johnson. Michael was an invaluable asset to the team, consistently producing the most Product Risk Analysis output by large margins; as well as providing mentoring to other consultants. I would be delighted to work with Michael again. I would also recommend or choose Michael for a leadership role on any team I was a part of or putting together.”
Benjamin Mills
Quality Engineering Consultant
Johnson and Johnson, Inc. (Formerly: DePuy Synthes)