Position: Manufacturing Quality Engineer

Location: Fremont, CA - 94538

Duration: 9 Months

Job Type: Contract

Work Type: Onsite

Shift: Monday to Friday 08:00 AM to 05:00 PM

Pay Rate: $ 30-35/Hourly/W2

Overview:

TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity below is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.

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 be driven 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 promptly
• 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 of 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 summarize results
• • The following experiences/skill sets are highly desirable: ISO 13485, ISO 14971, and statistical techniques.

TekWissen® Group is an equal-opportunity employer supporting workforce diversity.