Kelly Services
Location
Fremont, CA | United States
Job description
Location: Fremont, CA
Payrate: $37.50
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.
#P2
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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