Elizabeth Mclain Email and Phone Number
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Elizabeth Mclain is a Executive VP Operations, RA/QA at Walker Downey & Associates at Walker Downey & Associates. She possess expertise in fda, capa, iso 13485, quality system, medical devices and 17 more skills. Colleagues describe her as "I know Beth for over 5 years. I had the pleasure of conducting both an external audit with her as well as internal auditing within Philips Healthcare (PH). Beth was responsible for managing the post marketing surveillance activities in one of the major PH facilities. I know Beth's tenacity (fair and balanced) and professionalism with utmost integrity. She is trustworthy, diligent, and extremely dedicated to quality and never loosing the sense of business urgency. I highly recommend her for both regulatory and quality activities.", "I have had the pleasure of working with and being mentored by Beth McLain in RA role in PHILIPS. Beth’s expertise and experience in the RA/QA is exemplary. In my experience working with her in MDR reporting, Field Corrections-Removals and FDA audits, her dedication and subject-matter knowledge is an asset to any organization.", and "Beth exemplified being a thorough, detailed professional in her work. Her diligence and expertise in QMS, risk and post market surveillance are an asset to the company. Beth is well organized and her project management skills should be highly sought. She made my job a lot easier."
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Executive Vp Operations, Ra/QaWalker Downey & Associates Jan 2013 - PresentVerona, Wi, UsManage the day to day business operations for Walker Downey and Associates. • Conduct external audits for clients as requested to evaluate conformity to supplier requirements and to other regulations as required by ISO and FDA.• Assist in regulatory strategy for client submissions.Certified Veteran Owned Small Business (VOSB)
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Vp OperationsWalker Downey & Associates Dec 2012 - PresentVerona, Wi, Us
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Manager, Regulatory AffairsPhilips Medical Systems Feb 2004 - Dec 2012Amsterdam, Noord-Holland, NlCQA - 15 YearsManaged the Adverse Event Reporting and C&R process operations for CT/Nuclear Medicine and PROS. • Conducted product safety committee meetings for CT/Nuclear Medicine products to evaluate the potential safety assessments and required post marketing activities. (ISO 14971:2007)• Filed MDRs, Vigilance Reporting, and conducted recall coordination activities as needed.• Provided support for FDA Inspections.• Maintained and reported vigilance related statistics to Sr. Director RA/QA.• Direct interaction with the FDA for product recalls.Managed the technical complaint operations. • Managed 5 complaint investigators and one temporary employee.• Conducted product safety committee meetings to evaluate the potential safety assessments and required post marketing activities. (ISO 14971:2007)• Filed MDRs, Vigilance Reporting, and conducted recall coordination activities as needed.• Maintained and reported complaint statistics to Sr. Director RA/QA.• Completed complaint resource needs and obtained additional permanent head count and 3 full-time engineering support staff.• Provided support to both corporate audits and third party audits (FDA and Notified Body). -
Qa AuditorPowderject Vaccines 2003 - 2004Us• Conducted all vendor audits as required by FDA.• Maintained vendor audit approval system.• Reviewed all equipment and calibration records.• Performed a gap analysis and facilitated 21 CFR 58 compliance for the preclinical toxicology group. -
Qa AuditorTeleflex Medical 1999 - 2002Wayne, Pa, Us• Conducted all internal audits as required by FDA and ISO.• Conducted external audits of all contract sterilization facilities.• Maintained and reported CAPA statistics to V.P. RA/QA.• Actively participated in ISO recertification audits conducted by Notified Bodies. -
Sr. Quality AuditorBecton Dickinson Sep 1997 - Aug 1999Franklin Lakes, New Jersey, Us• Internalized the quality auditing function for WMT.• Identified, hired and managed a permanent employee.• Completed the design and the development of QA check sheets for auditing.• Trained new employee on phase audits, final report review, and documentation techniques.• Championed training courses for interpersonal skills and GLP regulations for the Toxicology Department.• Acted as primary internal quality auditor and performed GLP phase audits and vendor audits as necessary. • Created and maintained an auditing schedule assuring compliance to GLP regulations.• Consulted on the Becton Dickinson Quality/Safety Team in development and implementation of methods for auditing of safety practices and procedures in all facility laboratories.• Acted as primary QA contact for FDA audit. -
Food ScientistInternational Paper 1989 - 1996Memphis, Tennessee, Us
Elizabeth Mclain Skills
Elizabeth Mclain Education Details
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North Carolina State UniversityFood Science
Frequently Asked Questions about Elizabeth Mclain
What company does Elizabeth Mclain work for?
Elizabeth Mclain works for Walker Downey & Associates
What is Elizabeth Mclain's role at the current company?
Elizabeth Mclain's current role is Executive VP Operations, RA/QA at Walker Downey & Associates.
What is Elizabeth Mclain's email address?
Elizabeth Mclain's email address is el****@****ips.com
What is Elizabeth Mclain's direct phone number?
Elizabeth Mclain's direct phone number is +160821*****
What schools did Elizabeth Mclain attend?
Elizabeth Mclain attended North Carolina State University.
What skills is Elizabeth Mclain known for?
Elizabeth Mclain has skills like Fda, Capa, Iso 13485, Quality System, Medical Devices, Regulatory Affairs, Iso 14971, Regulatory Requirements, Quality Assurance, Design Control, Validation, Quality Auditing.
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