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Hello,

Hope you are doing great.

This is Kristopher Clarke from Intellectt INC; we have an immediate opportunity. Please find the below job description and if you are interested, please forward your resume to kris@intellectt.com (OR) What's App - (link removed)

Role: Development Quality Engineer II

Location: Menlo Park, CA

Duration: Long Term

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.