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Senior Quality Engineer

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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.

Senior Quality Engineer

  • 2020-13201.1
  • Hercules, California, United States

Bio-Rad is seeking an experienced Senior Quality Engineer to lead standardization and implementation of global process improvements that drive product and process quality reporting across our diverse global network. This this role will also be key to Bio-Rad’s Risk Management and Post Market Surveillance programs that drive strategic business decisions. This role will collaborate with multiple sites in the US, Europe and Asia Pacific which will require remote meetings and future occasional travel with teams located outside of the Hercules/Benicia CA location.

Responsibilities

  • Establishing a strategy and step by step approach for implementation of corporate Quality metrics and reporting. Also leading and overseeing a risk-based work plan to accomplish the strategy within a fixed project schedule.
  • Partnering with Regulatory Affairs, Clinical Affairs, R&D, Marketing and Manufacturing to produce new documentation evaluating initial and on-going product performance through the lifecycle of the product.
  • Leading global cross-functional process improvement projects that enable and improve visibility of quality issues and improved quality decision making from the manufacturing floor up to the executive leadership team.
  • Compiling and analyzing information to identify unacceptable trends and benefit-risk conclusions with the goal of driving suitable corrective actions needed to maintain safe and effective products and compliant processes.
  • Mentoring peers and lower level Quality Engineers as a Change Agent and subject matter expert for Quality System requirements and industry best practices.
  • Assisting RAQA leadership with communication of project status and needs to executive management team members.

Qualifications

  • Bachelor's degree or equivalent in Biology, Chemistry, or related field.
  • 8+ years' experience in a regulated manufacturing industry or equivalent combination of education and experience.
  • Advanced knowledge of and application of Quality Systems Engineering, Lean Six Sigma and Metrics/Statistics Reporting required.
  • Proven ability to collaborate and influence with or without authority, facilitate groups with diverse perspectives and align teams.
  • Regulatory experience or RAC is desired.
  • Detail-oriented, excellent organization and project management skills are needed to meet expectations.
  • Decision making, time management, communication, leadership, and computer skills.
  • SalesForce, SAP and Power BI experience is a plus.

 

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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