Aaron Snyder, Msc, Cgmp Email and Phone Number
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As a QMS foresight leader, learner, trainer, consultant, and innovator I am a recognized authority in leading QA teams to define and implement QA processes to withstand regulatory review for efficiency and compliance. I am an expert in understanding FDA cGMP regulations (both medical device & pharmaceutical) where I train industry and FDA leaders.As the Global Quality Systems Director at Mӧlnlycke Healthcare I drove process simplification leading to improved compliance through the implementation of three MasterControl Quality System processes (Document Control, CAPA, and Nonconforming Product). My extensive QA leadership, expertise, and communication skills led to being recognized by the AAMI as an expert lead faculty member where I teach both FDA personnel and Industry about QMS. I am approved to teach four different QMS courses. To date I have taught over 800 FDA employees and 1200 attendees from industry.I believe in integrity, treating people with respect, and making a difference. As a Quality Assurance executive my goal is to ensure safe and effective products are sent to patients. I thrive working in a fast-paced environment driving action and change. Collaboration is key. I enjoy being hands on working side by side with all levels of employees. I find great satisfaction in helping team members grow, learn, and earn promotions. I like building strong teams, educating every organization (both internal and external), and helping the business make more informed decisions. I am not your typical Quality trainer, I have led numerous training workshops in cGMPs, process validation, CAPA, failure investigation, and quality auditing where I engage with humor outlined from personal experience. As a member of Toastmasters International I received two advanced communicator gold awards and have presented hundreds of toastmaster speeches one of which won the 2009 District 31 humorous speech contest. I have certifications from American Society of Quality (ASQ)Quality Engineer (CQE), Software Quality Engineer (CSQE), and Six Sigma Black Belt (SSBB). I am an Exemplar certified Lead QMS auditor for both ISO 13485 and 9001. I have a M.S. from Northeastern University in Regulatory Affairs and two B.S. degrees from Purdue University in Mathematics and Industrial Management. I am open to QA consulting and Vice President QA positions within medical devices Class II or III, pharmaceutical or highly regulated manufacturing sectors. Contact: wsnyder2@gmail.com
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Quality Assurance Lead ConsultantQuality Systems ExplainedBoston, Ma, Us
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Vice President Quality AssuranceAllotex Jan 2023 - PresentBoston, Ma, Us
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Lead Faculty | Trainer For Fda And Industry Personnel, 21 Crf 820 And Iso 13485:2016 SmeAami Apr 2015 - PresentArlington, Virginia, Us21 CRF 820 and ISO 13485:2016 Lead Faculty for the non-profit organization founded to advance knowledge within the medical device industry through consensus standard, training, and regulator/industry collaboration. Taught over 100 FDA employees and 400 industry attendees. Approved to teach the Quality System Requirements & Industry Practices, Design Controls Requirement & Industry Practice, Purchasing Control & Supply Chain Management, & Corrective and Preventive Action Requirements & Industry Practice. Served as reviewer for curriculum update of the Quality System Requirements and Industry Practice course. Provided in-house training to FDA staff, private courses for multiple major Medical Device companies, and public courses to QA professional across the globe. -
Head Of Quality AssuranceFresenius Kabi Apr 2021 - May 2023Bad Homburg, Hessen, De -
Director Global Quality Assurance | Qa Executive, Strategic Planning, Change AgentMölnlycke Nov 2018 - Mar 2021Gothenburg, SeDirector Global Quality Systems for Molnlycke Healthcare, a leading manufacturer of innovative, high-quality wound management products that provide a holistic and caring approach to the patient. Led Quality System team and spearheaded audit to become EU MDR certified. Developed, coached, and mentored employees across functional teams to improve cGMP knowledge. Managed multiple external audits (FDA, MDSAP, MDR, etc.) which included pre-audit planning & training, front room & back room support, & the drafting audit responses to identified non-conformances. Report to Vice President QA. -
Senior Quality Assurance Manager | Sr Qa Leader, Strategic Planning, Change Agent, Problem SolverWaters Jun 2013 - Oct 2018Milford, Ma, UsAt Waters I built a high performing QA team that lead the organization forward. I defined the improvement strategy, procured the resources from the top management, built the organization, and then managed execution of the improvement strategy. We hosted an FDA inspection in June 2018 where I led the preparation and planned efforts. The inspection closed with zero 483s. -
Quality Assurance Manager | Qa Leader, Continuous Improvement, Fda Audit Management, Problem SolverCovidien Sep 2011 - Jun 2013Fridley, Minnesota, UsPlant QA Manager leading a comprehensive design transfer of all product lines overseas while at the same time launching two new next generation medical devices. Both next generation medical devices were launched on time and when I left the design transfer was ~75% complete. My team managed an FDA inspection in March 2013 that resulted in zero 483s. I led investigations into numerous high profile quality failures finding root cause and helping the organization remediate the problems. -
Project Manager Regulatory Compliance | Qa Leader, Qms Expert, Fda Audit Management, Problem SolverCovidien Feb 2011 - Aug 2011Fridley, Minnesota, UsCorporate QMS auditor and manager for the Corporate Audit team. I led the quarterly update of the Site Risk Assessment which summarizes all compliance risks for each location. Using the Site Risk Assessment, I defined, updated, and implemented the quarterly corporate audit schedule which had to be approved by the Sr. VP of Regulatory Affairs. While working at Covidien I conducted and/or lead over 150 Quality Audits. Finally, I implemented a quarterly interactive Lessons Learned presentation that shared QMS performance data across all sites and highlighted industry trends.
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Corporate Regulatory Compliance Specialist | Qms Auditor, Team Leader, Executive CommunicationCovidien May 2009 - Jan 2011Fridley, Minnesota, UsI led Corporate Quality Audits across all (64 plus) Covidien sites covering 21 CFR 820, 21 CFR 803, 21 CFR 806, Part 11, ISO 13485, 21 CFR parts 211, Q7 Active Pharmaceuticals, JPAL, CMDCAS, and many other standards and regulations. The Covidien site consisted of both Medical Device and Pharmaceutical manufacturing plants. Our audits covered class I, II, and III medical devices as well as drug products. The facilities included all Mallinckrodt Pharmaceutical sites, design and service centers, test laboratories, Distribution Centers, sterilization site, and medical device manufacturing sites. and Business Unit Corporate locations. I also ran the internal audit program at the Covidien corporate campus in Mansfield Massachusetts. I supported multiple FDA inspections, helped sites remediate quality system issues, and led multiple QMS training workshops across the global.
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Senior Quality Engineer | Qms Auditor, Team Builder, Problem SolverCovidien Dec 2006 - Apr 2009Fridley, Minnesota, UsAs a Sr. Supplier Quality Engineer, I focused on remediated a large supplier quality audit backlog (over 60 audits), improved the complaint investigation process for suppliers, identified and implemented company system enhancements for supplier complaints, and supported the launch of five highly successful new products. I conducted over 80 supplier audits and managed all audit closeout activities. I managed over 30 finished device suppliers. QMS audits around the work and visited customer sites to conduct quality investigations.
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Senior Quality EngineerCardinal Health Jun 2004 - Dec 2006Dublin, Oh, UsAs a Regulatory Component Qualification Analyst, I lead a project with remediated missing regulatory data and allowed the company to save over $500K in scrap inventory charges. I lead another project to review an entire warehouse of unused product leading to over $200K in savings. The then moved into a Sr. Quality Engineer position where I defined and implemented a supplier quality management system for my business unit. This program helped reduce in-process defects, improve supplier communication, and finally reduce customer complaints. I led the plant level investigation into a major product quality failure related to odor within products. Finally, I worked with a supplier to investigate and solve major product contamination nonconformances within gauze coming from China. -
Techical CoopGeneral Electric Aug 2001 - Aug 2003Boston, Ma, UsWhile in college I did three highly successful Technical Coop rotations at General Electric’s Appliance Park in Louisville KY. My first rotation was as a business team leader for a dish washer manufacturing line where I supervised ~80 union employees each day working to achieve production goals. My major achieve was that I improved process efficiency by eliminating variation leading to 23 days of consecutive achieving production numbers (never done before on my manufacturing line) and during my six months in the job making my numbers over 90% of the time. My second rotation was in Design Engineering working on refrigerators. My major achievement was the design of a new motor harness clip to solve a series of out of the box failures which resulted in significant cost savings. My last rotation was in Supplier Quality for the Washing Machine manufacturing line where my major achievements was working with supplier to solve intermitted motor failures. I led defining rework processes and also investigated many other quality failures.
Aaron Snyder, Msc, Cgmp Skills
Aaron Snyder, Msc, Cgmp Education Details
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Northeastern UniversityAnd Medical Devices - International Ra Concentration -
Purdue UniversityMathematics
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Purdue UniversityIndustrial Management
Frequently Asked Questions about Aaron Snyder, Msc, Cgmp
What company does Aaron Snyder, Msc, Cgmp work for?
Aaron Snyder, Msc, Cgmp works for Quality Systems Explained
What is Aaron Snyder, Msc, Cgmp's role at the current company?
Aaron Snyder, Msc, Cgmp's current role is Quality Assurance Lead Consultant.
What is Aaron Snyder, Msc, Cgmp's email address?
Aaron Snyder, Msc, Cgmp's email address is aa****@****cke.com
What schools did Aaron Snyder, Msc, Cgmp attend?
Aaron Snyder, Msc, Cgmp attended Northeastern University, Purdue University, Purdue University.
What skills is Aaron Snyder, Msc, Cgmp known for?
Aaron Snyder, Msc, Cgmp has skills like Quality System, Iso 13485, Fda, Medical Devices, Quality Assurance, Leadership, Six Sigma, Integrity, Quality Auditing, Capa, Passion For Learning, Listening.
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