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Online Resumes with "QSR ISO 13485"

QA/RA Manager / Senior Quality Engineer

I am seeking a like position with both challenge and room for unique contributions my background and experience can bring. I am willing to relocate for the right opportunity.

Ideal Companies: New Start-ups

Tags for this Online Resume: Company-Wide Quality Systems design, development & Certification to FDA/QSR, ISO13485 and all other associated regulatory requirements in both domestic and international markets for a broad range of Class I, II & III Medical Devices, Documentation/Data Control Management – CFR21 Part 11 Compliant, Develop/Manage Contractor-Supplier-Customer Partnerships (Internal & External) for Custom & Off-the-Shelf materials and components fabrication, assembly, sterilization, packaging, storage & distribution from Domestic & Global resources, Strategic Planning for Products / Budgets & P/L Responsibility, Lead Auditor for External QS Audits / Develop & Manage Internal Audit Programs, Post Market Surveillance Management, including Customer Service & Compliant Handling, for Continuous Improvement Program

Director of Engineering, Medical Device, Irvine, San Diego

Manage engineering design and development of medical device. New product and sustaining engineering. FDA QSR ISO 13485 medical device manufacturing support. Manage global teams. Overseas manufacturing in Asia and Mexico.

Medical Device, Process Quality Engineer - 20 Years of Experience - Near 95376

Summary of qualifications Accomplished and experienced self-starting Quality Assurance (QA/QE/QC) professional with over 20 years' experience in class 1, class 2, and class 3 electromechanical and single use sterile medical devices. Ability to deliver and manage projects simultaneously. Extensive knowledge of QSR, and ISO13485 quality system requirements. Highly collaborative team player.

Tags for this Online Resume: Test, Quality, Documentation, Failure Analysis, Engineering, Radiation, Medical Device, ISO13485, Clean Room, Sterilization

Clinical Pharmacovigilance/Drug Safety

A successful Documentation Control Management professional with over 30 years of experience in the Pharmaceutical and Medical Device industry. Excellent communication and interpersonal skills. Committed to motivating and empowering employees to consistently meet or exceed customer expectations and business needs with the following experiences: Quality Management Systems (QMS) development and implementation (QMS was based on...

Tags for this Online Resume: BPI, Documentum, Document Control, Management, Project Management, Documentation Management, Pharmaceutical, Medical Device, Biotech

Department Manager - 20 Years of Experience - Near 92128

Areas of Expertise * Business Process Improvement * Environmental Monitoring * Inventory Control & Management * Production Planning & Scheduling * Strategic Planning & Implementation * Process Design & Validation * GMP and ISO 13485 Compliance Recruited to establish Production Reva Medical San Diego, CA Established and directed formal operations functions supporting production of pre-clinical and clinical supplies collabore...

Tags for this Online Resume: Automation, Hazardous Waste, Instrumentation, Integrate, Metrics, Order Processing, Process Improvement, Production Metrics, Management, Good Manufacturing Practices

Quality Assurance Director - 20 Years of Experience - Near 92336

A successful Documentation Control Management professional with over 30 years of experience in the Pharmaceutical and Medical Device industry. Excellent communication and interpersonal skills. Committed to motivating and empowering employees to consistently meet or exceed customer expectations and business needs with the following experiences: Quality Management Systems (QMS) development and implementation (QMS was based on...

Tags for this Online Resume: Documentation, Management, Project Management, Pharmaceutical, documentation control, documentation management, quality systems