Title : Development Quality Engineer Location : Menlo Park, CA Duration : 12 months initial contract Job Description:
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)
Qualifications:
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
