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Job Information
Job title

Head, QA-Medical Device

Company PPD (Pharmaceutical Product Development, Inc.)
Wage between $0.00 - $0.00 Annually
Location United States, Wisconsin, Middleton
Employment type Full Time
Education Bachelor
Year Experience 3 - 4 Years of Practical Experience
Travel About 25%
Published on 10/24/2004
Description
This position has responsibility for the development and execution of a Quality Management Systems as defined by the U.S. and global Medical Device regulations and expectations of PPD clients. Specifically, the Head, Medical Device QA conducts internal audits of PPD processes and systems, audits computer validation documentation in collaboration with the functional department, defines issues and problem solutions strategies, establishes quality and performance matrices and analyzes trends and presents results to peers and senior management. The position serves as the corporate subject-matter-expert for the development and delivery of training initiatives regarding medical device compliance and computer validation.

This individual in this role will:have a strong, take-charge leadership skills, leading through cooperation, teamwork, and influence; successfully handle multiple responsibilities, priorities and tasks with minimal supervision; have excellent oral and written communication skills; have excellent interpersonal skills; have excellent facilitation and consensus building skills; successfully apply proven problem-solving techniques (Six Sigma, TQM, etc.); be an expert in interpreting and implementing 21 CFR Parts 50, 56, 312, ICH GCPs, European Directive and related FDA and international guidance documents on clinical research and drug development; be knowledgeable in 21 CFR Part 11 and EDC systems use in clinical research; have the ability to use statistical analysis software (SPC software).

This positon requires a Bachelors degree in Computer sciences, Medical Engineering, or Sciences/Healthcare and a minimum of 5 or more years combined experience in: Medical Device Regulatory Affairs/QA; application of computer validation/21 CFR Part 11 quality principles to business or scientific tasks; successfully developing and implementing Quality Management Systems; auditing clinical research sites and vendors or the equivalent combination of education and experience that provides the required knowledge, skills, and abilities to perform the job.df-tc

Experience/Skills
See Job Description

Other desired skills:
Head, QA-Medical Device
This job has expired.