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Quality Engineer III - Pleasanton, United States - Clinch
Description
Be part of the digital biology revolution...Bio-Rad is a leader in the development of innovative droplet digital PCR systems.
Bio-Rad's QX200 ddPCR system represents a new era in reliability and affordability across a range of applications for life science researchers and molecular diagnostics developers.
The QX200 combines precise microfluidic technology and proprietary chemistries to enable fine, absolute, and relative quantitation of DNA and RNA from complex and precious sample matrices.
This Quality Engineer III will be primarily responsible for customer product complaint handling for Bio-Rad DBG products.
A secondary responsibility will be investigating product / supplier quality issues and performing supplier audits in compliance to ISO 13485 and FDA QSR's.
Responsibilities
Responsible for the review, evaluation and closure of customer product complaints.
Supports complaint escalation investigations.
Supports the maintenance of quality processes to ensure that all product complaints are processed in accordance with established company procedures and standards, including but not limited to assessing risk, investigating root cause, implementing effective long-term corrective actions to prevent recurrence, and potentially reportable events.
Responsible for ensuring all required information for a complaint file is obtained and properly documented.Evaluates all information to ensure appropriate analysis, investigation, and root cause is documented prior to complaint closure.
Ensure adequate information is received to warrant timely reporting, investigation, and closure of product complaints.
Responsible for analyzing product quality information and providing metrics (case escalations, product quality issues, trend information, etc.)
Responsible for investigating product / supplier quality issues and performing supplier audits.
Qualifications
Bachelor's degree in any science field.
5+ years' experience or equivalent combination of education and experience working in an FDA and/or ISO 13485 regulated environment.
Knowledge/experience in Product Complaint Handling and Post Market Surveillance.
Knowledge of the regulations/standards/directives:
FDA QSR/GMP, Medical Device Reporting (MDR), Quality Management Systems (ISO13485), Risk Management (ISO14971), In-Vitro Diagnostic Directive (IVDD)/In-Vitro Diagnostic Regulation (IVDR), Medical Device Directive (MDD)/Medical Device Regulation (MDR).
Knowledge and understanding of SCARs/S-CAPAs.Knowledge/experience in performing supplier audits.
Knowledge/experience in investigating product/supplier quality issues.
Knowledge/experience in medical devices including IVDs.
Detail oriented with excellent organizational and project management skills.
Excellent verbal and written communication, problem solving, analytical skills required.
Critical thinking skills, ability to multitask in a high-pace environment with fast deadlines, and ability to work well under pressure.
Contribute individually but work as a team.Effective communication with various departments.
Understands principles, theories, concepts and techniques related to customer complaints.
Advanced computer skills required, including MS Windows, MS Word, MS Excel (use of pivot tables/charts) and MS PowerPoint.
Knowledge/experience with Salesforce complaint management system.
Knowledge of Power BI Reports.
Knowledge of statistics, use of statistical methods/analysis.
The position may involve up to 30% travel as needed to support the job function.
About Bio-Rad:
Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products.
With a team of more than 8,000 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.
Agency Non-Solicitation:
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.
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