Tracy Mcdermott Email and Phone Number
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Tracy Mcdermott is a Senior Quality Engineer at Meridian Bioscience Inc.. They possess expertise in manufacturing, gmp, quality system, medical devices, product development and 29 more skills. Colleagues describe them as "I had the very good fortune of hiring Tracy as a Quality Engineer over 4 years ago. In that time, she has proved to be a highly competent and versatile engineer. Whether it be leading the effort to install and validate production equipment, investigating and recommending improvements to production processes, being the Quality representative during product development, or taking on the role of co-project manager for a new product development, Tracy has consistently performed above and beyond expectations. I would enthusiastically recommend Tracy to anyone looking for a strong, pleasant QE.", "I had the pleasure of working with Tracy during her AgaMatrix tenure. In my human resources capacity, I was involved in the hiring process and decision to have her join our team and never once regretted that decision. She is hard working, dedicated and always delivered on objectives. Above and beyond her skills, Tracy is a person of high character and known for her genuine kindness and good heart.", and "Tracy is a dedicated, well-rounded quality engineer who does the hard work needed to make a project succeed. She is a superb team player who interacts adroitly across all levels of the business and is an excellent liaison with customers and suppliers. From MSAs to FMEAs, from technical writing to project management, she has demonstrated the ability to add value to the business. At AgaMatrix, she provided QE support to product development teams, participated in internal quality audits, developed and distributed monthly production quality reports, and has received consistently positive feedback on her performance."
Meridian Bioscience Inc.
View- Website:
- meridianlifescience.com
- Employees:
- 707
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Senior Quality EngineerMeridian Bioscience Inc.Boston, Ma, Us
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Principal Quality Systems EngineerRapid Micro Biosystems Nov 2023 - PresentLowell, Ma, UsManage and maintain the company's Quality Management System while maintaining ISO9001 certification, CE markings and expected customer GMP compliance.Develop, lead and maintain a comprehensive suite of metrics supporting the Quality System and products and maintain schedule of reviews and planned improvements.Lead, manage the CAPA program and internal audit program. -
Senior Quality EngineerMeridian Bioscience Inc. Apr 2020 - Nov 2023Cincinnati, Oh, Us• Responsible for the following Quality System Processes for medical device manufacturing; Validation, CAPA, NCM, Supplier Controls and Internal Audits.• Responsible for weekly QRB meetings and monthly Quality Metrics Reviews. • Create and review IQ, OQ, PQ protocols and reports.• Support FDA audits and perform internal audits.• Assist in FMEA updates.
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Process Quality EngineerThermo Fisher Scientific Jan 2017 - Apr 2020Waltham, Ma, Us• Responsible for tracking and presenting Quality Metrics for the Optical Portable Analytical Instrument.• Participated in internal and external audits. • Reviewed and approved validations protocols and reports.• Investigated OOBFs and improved manufacturing procedures for the optical “engine”. • Provided quality support of risk analysis DFMEAs and PFMEAs.• Supported new product introductions by providing data such as manufacturing nonconformances, complaints and early life failures. -
Sr. Quality EngineerBio-Concept Laboratories, Inc. Sep 2016 - Jan 2017Salem, Nh, Us• Developed inspection and testing methods, prepared quality assurance plans, specifications, and procedures. -
Quality EngineerAgamatrix, Inc Mar 2012 - Sep 2016Salem, Nh, UsLead validation effort of medical device manufacturing processesDevelop validation master planCreate IQ, OQ, PQ protocols and approve reportsInvestigate raw material, in process and final product quality issuesGenerate monthly product quality reportDevelop inspection and testing instructions and methodsAssist in CAPA investigations and product Risk AnalysisLead FMEA effortsMember of internal audit teamAssist in program management -
Site Technical Manufacturing Manager, StsoProcter & Gamble Apr 2009 - Mar 2012Cincinnati, Ohio, UsValidation of manufacturing processes and cleaning of non-OTC and OTC drugs Investigation of quality issuesNew product development -
Quality EngineerThe Gillette Company 1996 - 2009• Wrote and executed performance qualifications for OTC drugs.• Participated in FDA audits. • Led Blitz Kaizen, implemented visual management and “6S” techniques, reduced waste by $70K/yr• Initiated process improvement of batching of shave foam, increasing yield by 100%.• Incurred cost saving of $240 K/yr by evaluating expel data and reducing fill weights.• Reduced sanitization time by +50% with a team on a capacity constrained line.• Found cause of aerosol Foam clogging which reduced consumer complaints by 90%.
Tracy Mcdermott Skills
Tracy Mcdermott Education Details
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University Of Massachusetts LowellChemical Engineering
Frequently Asked Questions about Tracy Mcdermott
What company does Tracy Mcdermott work for?
Tracy Mcdermott works for Meridian Bioscience Inc.
What is Tracy Mcdermott's role at the current company?
Tracy Mcdermott's current role is Senior Quality Engineer.
What is Tracy Mcdermott's email address?
Tracy Mcdermott's email address is tr****@****rix.com
What is Tracy Mcdermott's direct phone number?
Tracy Mcdermott's direct phone number is +181523*****
What schools did Tracy Mcdermott attend?
Tracy Mcdermott attended University Of Massachusetts Lowell.
What skills is Tracy Mcdermott known for?
Tracy Mcdermott has skills like Manufacturing, Gmp, Quality System, Medical Devices, Product Development, Project Management, Consumer Products, Process Improvement, Iso 13485, Process Engineering, Fda Gmp, Validation.
Who are Tracy Mcdermott's colleagues?
Tracy Mcdermott's colleagues are Kimberly O’connell, Sean Mcmillan, Katharina Hess, Samantha Cavanaugh, Laura Reid, Kat Pouliot-Mathieu, John Forsythe.
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