Development Quality Engineer # JN -052021-64395
Title : Development Quality Engineer
Location : Menlo Park, CA
Duration : 12 months initial contract
- Develop and Validate test methods for evaluation of product requirements
- Initiate, execute, and track role appropriate Design Controls quality deliverables
- Plan and execute Product Quality Risk Management activities with the cross functional development team (Failure Modes Effects Analysis, Risk Controls/Mitigations, Verification and Validation, etc)
- Develop and implement product and process inspection and monitoring requirements
- Collaborate and provide guidance to cross functional R&D and Manufacturing teams to establish verification and validation strategy
- Author and execute Design Verification, Shelf Life, and Process Validation studies protocols and reports
- Investigate and provide guidance and input in resolving deviations and non-conformances associated with Design Verification, Shelf Life, and Process Validation studies
- Perform and interpret appropriate data and statistical analysis of test results
- Execute work in compliance to applicable Standards and Regulations (e.g. CFR 820, EU MDR 2017 / 745, ISO 13485, ISO 14971, etc)
- Bachelor's degree plus 2-5 years of related work experience with a good understanding of specified functional area, or Master's degree with 0-2 years of related work experience, or an equivalent combination of education and work experience.
- (Technical/Business Knowledge (Job Skills)) Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
- (Cognitive Skills) Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment