Quality Engineer II - Intelliswift Software Inc
Fremont, CA 94538
About the Job
Job Description: As a Quality Engineer II, you will ensure compliance with local and international regulatory requirements related to product safety. The Quality Engineer II is responsible for working with technical subject matter experts to document product formula information/data for use in the creation of product safety documentation. The position may also be called upon to participate in other Quality System initiatives, such as working within the CAPA subsystem (SCAR, Complaint, CAPA, Non-conformance), design controls, risk management, or other areas within the Quality Assurance function..
Who we Want:
• 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.
Key Responsibilities:
• 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/Qualifications:
• Minimum BS/BA in scientific discipline (preferably chemistry or chemical engineering) with 2-5 years related experience
• 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.
Who we Want:
• 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.
Key Responsibilities:
• 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/Qualifications:
• Minimum BS/BA in scientific discipline (preferably chemistry or chemical engineering) with 2-5 years related experience
• 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.
Source : Intelliswift Software Inc