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Sarasota, FL
... QUALIFICATIONS Essential Duties and Responsibilities: Essential Duties and Responsibilities: · Experience with FDA, CFR and cGMP · SPC, Statistical Analyzer · Quality Control / Standards Process · Reliable, Model Technician EXPERIENCE Contract ...
- Feb 06
Bradenton, FL, 34205
... Strengths includes: Root Cause Analysis Project /Program Management Concise Communication Lean Six Sigma Lreen Belt Change Management Continuous Improvement Regulatory Expertise FDA, QSR, ISO and MDD Quality Auditing – ISO 9001/13485//14000 LEAN ...
- Feb 03
Bradenton, FL
... Competent in system documentation including FDA, ISO 9001, Quality Systems, SOP's, JSA's, and safety bulletins. • Manufacturing Savvy. • ASQ Membership and training. • Leadership/Coaching Skills. • Machine Modification skills. TPM, SAP. • Safety ...
- 2023 Dec 21
Bradenton, FL
... Directing and overseeing the FDA Quality Management System transition to the Amazon Cloud with our vendor Master Control. Manage and oversee a diverse team of senior level project leaders that are dispersed throughout the nation ensuring that all ...
- 2020 Jul 13
Parrish, FL
... / Optimization Compliance / SHE / Food Grade Requirements – Nestle NQMS, Kind GMP Audits, Responsible Sourcing, FDA Purchasing, procurement, supplier sourcing, planning and capacity management Vendor sourcing and on boarding Supply chain ...
- 2020 Jun 23
Sarasota, FL, 34239
... technology with numerous prominent surgeons § Designed implants, medical devices and systems used in surgery § Achieved 47 FDA regulatory clearances [approvals] § Awarded 49 patents and intellectual property filings § Wide ranging understanding of ...
- 2020 Apr 18
Sarasota, FL
... ICH GCP Guidelines/FDA regulations: 8 hrs class/10 hrs online 3. Protecting the Rights of the Patient: 2 hrs class/3 hrs online 4. Regulatory Affairs: 5 hrs class/3.5 hrs online 5. Dissection of a Protocol & Clinical Trial Budgeting: 10 hrs class 6. ...
- 2019 Apr 12
Sarasota, FL
... ERP System Agile Doc Control Internal ISO Auditor Government Purchases and Contracts Business Process Development SOX Compliance FDA, FAA & ISO Regulated Environments Medical Device and Aerospace Industries SalesForce.com Employment History L3 ...
- 2018 Mar 08
Sarasota, FL
... Processing Pharmaceutical Calculations Medical & Pharmaceutical Terminology Drug Classifications & Safety Medication Inventory Management FDA & HIPAA Compliance Medicare, Medicaid & Insurance Claims Processing Customer Service/Customer Relation
- 2017 Oct 27
Bradenton, FL, 34211
... FDA and TUV audit experience. Fair and motivational leader of diverse workforces and management teams. Gemba style. Core competencies include: LEAN Manufacturing & Kaizen Six Sigma/QA Strategic Planning & Execution Multi-Site Operations Team ...
- 2017 Aug 01