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Location

Fremont, CA | United States

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Job description

Chipton-Ross is seeking a Quality Engineer II in Fremont, CA.

RESPONSIBILITIES:
o Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
o Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
o Dedicated achievers. People who thrive in a fast-paced environment and will drive to ensure a project is complete and consistently meets expectations.
o Gather, analyze and document product formulas for use in the creation of Safety Data Sheets
o Ownership of activities that lead to improvement in Quality metrics
o Investigate and drive customer complaints related to product labeling to closure in a timely manner
o Support NC and CAPA process and NC and CAPA investigations
o Communicate with internal stakeholders to prioritize and complete requests to meet customer expectation
o Work with cross-functional teams (e.g.: R&D, Operations, Manufacturing Engineering, Service and Support, Product Management, Business Development, QA, QC, Regulatory Affairs) to drive resolution for internal issues/projects
o Supports completion and execution of Engineering Change Orders (ECOs) and Product/Process Change Orders (MOCs)
o Conduct/Update risk analyses and track all findings, along with the development of a Risk Management portfolio, as required.
o Calculate Failure/Harm occurrence rankings based on field data as required
o Provide input, feedback and data for Quality report outs, Management Review, etc.
o Support internal and external audits (FDA, ISO, MDSAP etc.)

REQUIREMENTS
o Experience in a regulated industry (medical device, in vitro diagnostics preferred)
o Experience and knowledge of investigation techniques and related tools: 8D, Root Cause Analysis, etc
o Strong organizational skills and attention to detail
o Must be able to write clear, understandable documentation
o High level of verbal communication skills
o Ability to manage multiple tasks simultaneously
o Ability to work independently
o Ability to perform simple data analysis and to summarize results
o The following experiences/skill sets are highly desirable: ISO 13485, ISO 14971, statistical techniques.

EDUCATION
o Minimum accredited BS/BA in scientific discipline (preferably chemistry or chemical engineering) with 2-5 years related experience.

WORK HOURS
Full-Time Monday - Friday 8:00 AM to 5:00 PM

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Job tags

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Salary

$37.5 per hour