Posted in Other 30+ days ago.
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Type: Full Time
Location: Hercules, California
# of Openings
Bio-Rad is looking for a Quality Assurance Analyst/QE Engineer to be based out of the Hercules Campus, supporting a variety of Bio-Rad Products, across multiple divisions.
* Will contribute to the continual improvement and maintenance of at least one of the following systems: Change Control, CAPAs, and/or Complaints/Post-Market Surveillance.
* Will perform a combination of the following: Risk Assessment, Root Cause Analysis, evaluating potentially reportable events, and the implementation of effective long-term changes/corrections.
* Responsible for evaluation and review of all information (i.e. protocols and/or reports) to ensure appropriate analysis, investigation, and root cause identification, from a QA/QE perspective, prior to case closure within the appropriate system.
* Will ensure adequate information is received to warrant timely reporting, investigation, and case closure, within the appropriate system, in accordance with established company procedures and stands.
* Will work cross-functionally with other departments, serving as the QA/QE subject matter expert, drafting and/or reviewing proposals or reports.
* May perform laboratory investigations on in-house instruments.
* Must hold at least a bachelor s degree in life sciences, chemistry, biology, or equivalent.
* Between 0-5 years of experience.
* Must be detail-oriented with excellent organizational and project management skills.
* Must have strong critical thinking skills and be able to function in a high-throughput environment, with potentially short timelines, and while working under pressure.
* Effective verbal and written communication skills, required.
* Basic computer skills is required, including but not limited to MS Windows, MS Word, MS Excel, MS PowerPoint.
* Experience in at least one of the following systems: Change Control, CAPAs, and/or Complaints/Post-Market Surveillance is a plus.
* Experience in working in a laboratory environment is a plus.
* Knowledge/experience with root cause analysis methods is a plus.
* Knowledge/experience with business systems, such as Salesforce Complaint Management System, EtQ, and/or SAP is a plus.
* Knowledge/experience with quality management systems operating under Medical Device Reporting (MDR), Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) under QSR/ISO 13485, or Risk Management (ISO 14971) regulations is a plus.\\"
Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.
Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.
Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.