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Online Resumes with "MDR reporting "
Began career with 10 years with the FDA in the Detroit District office and at the Kalamazoo, MI and Grand Rapids Resident Posts. Conducted inspections at pharmaceutical and medical device companies, conducted investigations and testified in court. I Left for a start-up medical device contract manufacturer where I developed the quality system and initiated 510(k) submissions. I also identified and resolved problems result...
Ideal Companies: Small to large medical device or pharmaceutical companies such as Abbott Laboratories, Baxter, CR Bard, Phillips, Medtronic, Boston Scientific, St. Jude Medical, Johnson & Johnson, Bausch and Lomb.
Seeking a position which will allow me to execute as well as challenge my current skill set resulting in performance growth and advancement. Exceptional verbal/written communication, organizational, leadership, analytical, and interpersonal skills
Detail-oriented and hardworking individual with more than 20 years of experience in the Medical Device industry. Highly qualified in Complaint Handling Medical Device Reporting and Post Market Surveillance functions.
Tags for this Online Resume: Administrative Assistant, Call Center Management, Management, Microsoft, Microsoft Excel, medical device, CAPA, complaints, MDR reporting, quality systems, quality audits, data analysis, post market surveillance
Areas of Expertise * Quality Engineer * Non-Conformance * Auditing * Product Surveillance * Training & Staff Development * Medical Device & Pharma * Complaint Review * Policy & Procedures * FDA/MDR Reporting * Subject Matter Expert * Complaint Investigation * 21CFR Part 210 and 211 * 21CFR Part 820 and 803 * ISO 9001, 13485 & 14001 * Laboratory Testing * Calibration and Validation * Federal Compliance * International Compli...
Tags for this Online Resume: Quality, Quality Assurance, Systems Operations, Documentation, Instrument Calibration, Notebook Computer, Project Coordinator, Process Improvement, Typing, Inventory, human resources