Lee Bateman Email and Phone Number
Lee Bateman work email
- Valid
- Valid
- Valid
- Valid
- Valid
Lee Bateman personal email
- Valid
Results-oriented and process-minded Quality Assurance and Regulatory Compliance Specialist / Technical Writer / Quality Engineer with over 10 years of pharmaceutical, biologics, and medical device industry experience in manufacturing environments. Proven success creating, implementing, and sustaining efficiency and compliance to domestic and international regulations. Expertise and key strengths include:• Interpreting, applying, and sustaining compliance to 21 CFR parts 210/211, 820, and 11 and ISO 9001, 13485, and 14971 • Quality Management System improvements (CAPA, Complaint Handling, Deviations, Internal Audits, Quality Investigations, etc.)• Nonconformance & Complaint Investigations • Organizational excellence in start-up & consent decree environments• Process Mapping & Process Improvement • Facilitating and leading Root Cause Analysis• Failure Mode and Effects Analysis (FMEA) • GMP, GCP, & GLP compliance• Regulatory audit responses • QA approval of stability, validation, & other Quality-related documents, protocols, and reports• Electronic Quality Management Systems (EtQ/Symphony, SAP, Master Control) • Regulatory Affairs (FDA, ICH, CMDR/ Health Canada, & MDD)• Lean Six Sigma Black Belt principles • Quality Engineering Principles• Project Management & Process Excellence • Proven leadership and team collaboration skillsEDUCATIONB.A., Anthropology, University of Tennessee, Knoxville, TNMinors in Biology, Philosophy, and Political ScienceCERTIFICATIONSISO 9001 and ISO 13485 Lead AuditorApollo Root Cause Analysis Super UserMaster Control Super UserTechnical WritingPROFESSIONAL DEVELOPMENTLean Six Sigma Black Belt education (Villanova University)Project Management Professional (PMI)ISO 14971 (Risk Management)Statistical Process ControlsPROFESSIONAL AFFILIATIONSMember, Parenteral Drug Association (PDA)Senior Member, American Society for Quality (ASQ)Member, Association for the Advancement of Medical Instrumentation (AAMI)
Stryker
View- Website:
- stryker.com
- Employees:
- 48790
-
StrykerNashville, Tn, Us
-
Associate Quality Assurance ManagerStryker Oct 2023 - PresentKalamazoo, Mi, Us
-
Senior Quality Assurance Manager (Consultant)Nuline Sensors Llc Apr 2023 - Oct 2023Manage, oversee, and continually improve the QMS of NuLine Sensors. Work directly with executive leadership to bring about positive changes in efficiency and effectively create and maintain sustainable compliance across the organization. -
Senior Quality Engineer, Quality SystemsAccess Dental Lab Sep 2020 - Jan 2023Nashville, Tennessee, Us -
Quality Engineer, ValidationAccess Dental Lab Aug 2018 - Sep 2020Nashville, Tennessee, UsManaged, authored protocols, executed, and approved compliance-focused validation activities from equipment qualification and process validation to software validation (CSV).
-
Quality EngineerSmiledirectclub Sep 2017 - Aug 2018Nashville, Tn, UsWorking with a small Quality team to establish the company’s Quality System from scratch and to file a 510(k). Establishing the Design History File and related verification and validation activities. Created and approved various procedures, work instructions, and forms across multiple teams within the company. Wrote and executed validation protocols for 3D printers. Worked with laboratories and suppliers to initiate and finalize analytical and biocompatibility testing for our products. Active team member providing a Quality System perspective for new and ongoing R&D projects related to our products and manufacturing processes. -
Regulatory Compliance & Validation SupervisorAutocam Medical Jan 2015 - Aug 2017Kentwood, Mi, UsIn charge of all validation activities and ensuring sustainable compliance while balancing company and customers needs. -
Quality EngineerAutocam Medical Jun 2014 - Jan 2015Kentwood, Mi, UsMain focus currently is writing and executing IQ, OQ, PQ, and PPQ for equipment that manufactures components for finished medical devices. I am qualifying the equipment and validating the associated processes. I am also helping the business find its regulatory path as they rapidly expand. Finally, my duties include Process Excellence initiatives to streamline existing Quality System processes to create sustainable regulatory compliance.
-
Lead Investigator (Consultant)Mcneil Consumer Healthcare Jan 2014 - Jun 2014UsConsulting as a Lead Investigator / Compliance Specialist for Manufacturing and Quality System nonconformances in a Consent Decree environment. -
Lead Investigator (Consultant)Mcneil Consumer Healthcare Aug 2013 - Jan 2014Us• Initiated, lead, wrote, reviewed, and approved investigations using the EtQ/Symphony electronic system for manufacturing nonconformances in a Consent Decree environment.• Closed investigations in a timely fashion to assist McNeil in restarting their consumer liquid dose manufacturing operations while the company was under Consent Decree.• Met with project teams, Operations, and Quality Assurance teams to ensure investigations were compliant and closed on-time.• Interviewed and collaborated with various departments to gather valuable information to close investigations in a timely fashion.• Performed root cause analyses.
-
Document Control, Training, And Manufacturing QaBerg Pharma Apr 2013 - Jul 2013Managed Document Control and Training. Re-engineered and managed Change Control and Training. Provided support for Manufacturing QA. Worked with all departments to improve existing processes; created risk-based GMP-compliance assessments, refined warehousing procedures and flow, created new document templates, managed document changes, made new Quality Systems documents effective, and facilitated root cause analysis and managed closure of the resulting CAPA action items.
-
Operations And Administration Manager (Entrepreneur)Mimlab Special Effects Studio Jul 2011 - Dec 2012Managed projects utilizing Lean Six Sigma Black Belt training, contributed to concept designs, and handled all administrative duties.
-
Quality Systems And Regulatory Compliance SpecialistBiomimetic Therapeutics Mar 2007 - Aug 2011Improved, oversaw, and maintained compliance to cGMPs and international (ISO) regulations of the following Quality Management System elements: lot release, corrective actions, preventive actions, internal audits, root cause analyses, deviations, management reviews and associated action items, regulatory audit finding responses, Continual Improvement per ISO 9001, Customer Satisfaction per ISO 9001, and gathering, analysis, and presentation of QMS metrics. I also transitioned the QMS from a paper-based system to an electronic system with no additional expense.
-
Quality Assurance CoordinatorDci Donor Services 2004 - 2006Nashville, Tn, UsEnsured donor suitability and recipient safety by reviewing the donor medical and social history and microbiological data. Used my prior experience as a member of tissue recovery teams and processing donor tissues to procure, process, and confirm suitability of donated human tissues.
Lee Bateman Skills
Lee Bateman Education Details
-
University Of Tennessee, KnoxvillePhilosophy
Frequently Asked Questions about Lee Bateman
What company does Lee Bateman work for?
Lee Bateman works for Stryker
What is Lee Bateman's role at the current company?
Lee Bateman's current role is Experienced and proven QMS and validation/CSV professional in active and transitional Medical Device/Pharma manufacturing environments.
What is Lee Bateman's email address?
Lee Bateman's email address is se****@****ail.com
What schools did Lee Bateman attend?
Lee Bateman attended University Of Tennessee, Knoxville.
What are some of Lee Bateman's interests?
Lee Bateman has interest in Family, Quality Engineering, Personal Interests, Professional Interests, Lean Six Sigma Black Belt, Project Management, Technical Writing, Nutrition, Science, Lean Manufacturing.
What skills is Lee Bateman known for?
Lee Bateman has skills like Quality Control, Fda, Quality System, Quality Assurance, Six Sigma, Lean Manufacturing, Operations Management, Manufacturing Operations Management, Business Analysis, Business Process Mapping, Iso, Business Process Improvement.
Who are Lee Bateman's colleagues?
Lee Bateman's colleagues are Katharina Kuron, Robert Mykytka, Brianna Caldwell, M.ed., Sosefina Lam, Ashok Parasa, Ruben Flores, Steven Rees.
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial