Quality Control Engineer

Company: Advantage Technical Resourcing
Location: Sunnyvale
Posted on: July 1, 2020

Job Description:

Position Overview Roles and Responsibilities This role has responsibility and authority for Quality Advocacy and Project Management Develop and apply corporate level quality metrics. Lead and project manage quality initiatives in one or more of these focus areas Product Quality Data Quality Process Quality Failure Analysis o Provide quality expertise post market release to the quality engineering support team to analyze the returned product. o Perform technical failure analysis based on the physics of failure. o Review and interpret complex data analysis rooted in an understanding of our product hardware and software, the physics of failure, and the use conditions in the clinical operating room environment. o Analyze and disposition of discrepant material. o Support manufacturing processes, including failure analysis, documentation review and approval, tooling qualification, and defect containment's. o Support development and execution of process validation and verification test plans, protocols, and reports Product Development o Handle projects of various product and subsystem types (Software, Mechanical Hardware, Camera, Disposable accessories like catheter, etc). o Development teams to develop measurable goals for quality. o Ensuring that the essential performance aspects are mitigated in the product quality plans. o Identify critical elements of designs. Recommend design processes and methods to meet quality goals DFX, etc. o Provide guidance to other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to the ISI products. o Plan and creation quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices. o Ensure process compliance through the design and development of comprehensive procedures including work instructions, flowcharts, forms, templates, checklists, and other product or process related documentation, for recording, evaluating, and reporting quality data. Qualifications RequirementsSkill Set Competencies Education Bachelor degree in electrical, mechanical or system engineering, math, or physics. Advanced degree preferred. 2+ years of working experience in Quality Engineering, minimum 2 years in medical device design or manufacturing environment. Able to navigate quality and compliance system with minimal oversight on individual projects. Demonstrated understanding of CFR 21 820 ISO 13485 requirements for making process or design changes. Understands product risk management, experience in generate FMEA and process FMEA. Understands Design Controls, Change Controls, Product, and Engineering Processes. Proficient with generate and execute Qualification and Validation protocol and Quality Assurance Procedures. Experienced in leading product containment and rework activities. Proficient in SPC Six Sigma methodology and tools (e.g. uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram). Understands typical Excel data analysis operations (e.g. Vlookup, Pivot table and pivot chart functions) in addition create Multi-source reports, trends, and interprets data with minimal oversight. Capable of thinking independently and make decision based on limited information. Capable of initiating improvement discussions and lead the team toward the goal. Can present information in various forms and forums to Sr. Management and collaborates well with peers across functions. (e.g. report writing, presentations, QRB presenter). Location Sunnyvale, CA At Advantage Resourcing, our primary objective is to perfectly align the best people with the appropriate jobs. These jobs may be temporary assignments or career positions. We place talented people in a wide variety of jobs working with our client companies in areas such as engineering, IT, technical, manufacturing, skilled trades, distribution, call centers, clerical, accounting, finance and sales. Our strength is being able to solve our client's workforce needs by matching people that have the right skills, knowledge and motivation to each opportunity. Advantage Resourcing can help you discover the personal and career success you desire. Advantage Resourcing Americas, Inc. is an Equal Opportunity Employer offering employment without regard for race, color, religious creed, national origin, ancestry, gender, marital status, age, sexual orientation, sex, gender identity, disability, veteran status, or other legally protected categories. Advantage Resourcing is a VEVRAA Federal Contractor.

Keywords: Advantage Technical Resourcing, Sunnyvale , Quality Control Engineer, Engineering , Sunnyvale, California