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Quality Engineer IIin Fremont, CA. This is a 9+ month contract opportunity.
Industry: Pharmaceutical/Medical Devices
Rate: Up to $37.50/hr
Duration: 9+ months
Locations: Fremont, CA (100% onsite)
JOB DESCRIPTION
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
- Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
- Dedicated achievers. People who thrive in a fast-paced environment and will drive to ensure a project is complete and consistently meets expectations.
- Gather, analyze and document product formulas for use in the creation of Safety Data Sheets
- Ownership of activities that lead to improvement in Quality metrics
- Investigate and drive customer complaints related to product labeling to closure in a timely manner
- Support NC and CAPA process and NC and CAPA investigations
- Communicate with internal stakeholders to prioritize and complete requests to meet customer expectation
- 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
- Supports completion and execution of Engineering Change Orders (ECOs) and Product/Process Change Orders (MOCs)
- Conduct/Update risk analyses and track all findings, along with the development of a Risk Management portfolio, as required.
- Calculate Failure/Harm occurrence rankings based on field data as required
- Provide input, feedback and data for Quality report outs, Management Review, etc.
- Support internal and external audits (FDA, ISO, MDSAP etc.)
MINIMUM REQUIREMENTS
- Experience in a regulated industry (medical device, in vitro diagnostics preferred)
- Experience and knowledge of investigation techniques and related tools: 8D, Root Cause Analysis, etc
- Strong organizational skills and attention to detail
- Must be able to write clear, understandable documentation
- High level of verbal communication skills
- Ability to manage multiple tasks simultaneously
- Ability to work independently
- Ability to perform simple data analysis and to summarize results
- The following experiences/skill sets are highly desirable: ISO 13485, ISO 14971, statistical techniques.
EDUCATION
- Minimum accredited BS/BA in scientific discipline (preferably chemistry or chemical engineering) with 2-5 years related experience.
HOURS
Monday-Friday 08:00 am to 5:00 pm
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
# 209984
Chipton-Ross is a highly awarded top 500 Women owned business that is dedicated to locating and placing top-quality talent. We specialize in Engineering, Manufacturing, Light Industrial, Information Technology, Professional, Administrative, and Logistics.
