Aaron Snyder, Msc, Cgmp Email & Phone Number

Boston, MA, US

Boston, MA, US

Arlington, Virginia, US

21 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.

Bad Homburg, Hessen, DE

Gothenburg, SE

Director 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.

Milford, MA, US

At 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.

Fridley, Minnesota, US

Plant 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.

Fridley, Minnesota, US

Corporate 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.

Fridley, Minnesota, US

I 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.

Fridley, Minnesota, US

As 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.

Dublin, OH, US

As 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.

Boston, MA, US

While 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.

Master Of Science (Ms), Regulatory Affairs For Drugs, Biologics, And Medical Devices - International Ra Concentration

Bachelors, Mathematics

Bachelors, Industrial Management