ASTRAZENECA PHARMACEUTICALS LP – $162,157.00/Year

Must have a Bachelors degree or foreign equivalent in Engineering any or a related field plus ten 10 years of progressively responsible experience in the position offered as a Design Quality Engineer or a related position.br Must have ten 10 years of progressively responsible experience in each of the following US and International Design Control and Risk Management requirements including 21 CFR Parts 4, 210, 211, 803, 806, 820.30, ISO 13485, ISO 14971, and EU Medical Device Regulations; Risk assessment tools, including Failure Mode and Effect Analysis tools, Fault Tree Analysis, and Hazard Assessment; Authoring technical specifications and design control documentation including Design Development Plan, User Requirements Specification, Design Input Specification, Design Outputs, Design Reviews, Design Verification Master Plan and Reports, Design Validation PlanReport, Design Transfer and Verification PlansReports, Human Factors studies Formative, Summative and Summary PlanReports, Risk Management Suite Risk Management PlansReports, Use Failure Mode and Effect Analysis, Design Failure Mode and Effect Analysis, Design Master Records, and conformity assessments; Providing quality engineering support for the investigation and trending device designrelated complaint records using relevant techniques including 5Ms, Fishbone, Mann Kendall Trending, and Control charting Poisson and Negative Binomial distributions; Providing quality guidance in handling nonconformances related to the medical device development process, including investigations for root cause using 5 Whys, 5Ms, and Fault Tree Analysis tools; Providing quality and technical support for the evaluation of change assessments for the combination product Quality system; Evaluating the suitability of test methods and equipment for verification testing, including developing riskbased validation planning Installation Qualifications and Operation Qualifications, Precision and Accuracy management under general fit for use type performance testing; Developing suitable riskbased sampling plans for design verification and validation testing and leading relevant risk assessment and control planning activities; and Using Geometric, Dimensioning, and Tolerancing principles including Maximum and Least Material requirements, Stacked Tolerance chains, and PositionalVectorStatistical Tolerancing.br br Alternatively, the employer will accept a Masters degree or foreign equivalent in a stated field plus eight 8 years of experience. Any suitable combination of education, training or experience is acceptable.