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Quality Engineer II

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Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information from applicants. Be aware that Bio-Rad strictly adheres to these hiring practices.

Quality Engineer II

  • 2020-13219
  • Hercules, CA, United States

Bio-Rad is seeking a quality engineer to join the Northern California QA Quality Engineering Team to support risk management, post-market surveillance, complaint investigations, CAPAs, and customer requests programs.

Responsibilities

  • Supports product and process complaint and CAPA investigations utilizing problem solving and statistical tools including identification of root cause and implementation of applicable corrective and preventive actions.
  • Evaluates information to ensure appropriate analysis and root cause is documented, reviewed and approved prior to investigation closure.
  • Lead and/or coordinate post-market surveillance and risk management activities such as documenting risk assessments, updating risk management files (dFMEA/pFMEA), writing and/or updating risk plans and reports as well as coordinating post-market surveillance plans and reports.
  • Identifies and analyzes actual and potential causes of risk, consequences and control measures.
  • Responsible for analyzing product quality information (case escalations, trend analysis, service activities, etc.) including providing technical and analytical support to subsidiaries and internal functional areas.
  • Develops and implements appropriate process monitoring and control methods consistent with the level of process/product risk. This includes continually evaluating existing processes for improvement.
  • Assists in the design review of new or modified products. Supports new product development and new product introduction activities including reviewing and approving plans, reports and protocols and supporting equipment and processes qualifications and validations as needed.
  • Challenges designs to ensure manufacturability, safety and effectiveness of products.
  • Analyzes nonconformances, complaints and trend information to identify and recommend corrective actions.
  • Supports product improvement projects and supplier changes to ensure validation requirements are met.
  • Collaborates with manufacturing, R&D and regulatory functions to ensure appropriate quality standards are in place and consistently met.
  • Work effectively with all levels of management to ensure action plans can be supported and that costs/resources needed to implement the plan are available.
  • Supporting a wide range of continuous and process improvement initiatives, including creating process flow maps, procedures and training materials.
  • Support other quality and compliance activities as required including supporting internal, external and regulatory audits and inspections.
  • Help to drive and foster a quality environment and mindset throughout the business.

Qualifications

  • Bachelor’s Degree in a scientific or engineering discipline.
  • 2+ years experience or equivalent combination of education and experience managing root cause investigations.
  • Critical thinking skills, ability to multitask in a high-pace environment with fast deadlines, and ability to work well under pressure, is required.
  • Basic knowledge of and application of principles and theories of quality engineering.
  • Understanding of GMP/ISO regulations (ISO 13485, ISO 14971, FDA) and validation regulations.
  • Detail oriented with excellent organizational and project management skills.
  • Excellent verbal and written communication, problem solving, analytical skills required.
  • Contribute individually but work as a team.
  • Effective communication with various departments.
  • Basic computer skills required, including MS Windows, MS Word, MS Excel, MS PowerPoint, SAP.
  • Knowledge/experience with Salesforce complaint management system is a plus.
  • Experience with statistical methods, process control, design control and change management within a regulated environment.
  • Preferred experience working in a global multiple-site company with multiple quality systems.
  • Preferred experience working with class II IVD products and research use only products.
  • Quality Engineering, Six Sigma Green Belt certification desirable.

 

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.

EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age

 

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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