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Quality Engineer I

Quality Engineer I

  • 2022-28981
  • Woodinville, Washington, United States

Bio-Rad is seeking a competent Quality Engineer or Scientist to lead quality engineering activities for IVD product lines, including material review board, management of non-conformities and participation in CAPA, change control and validation.  This position requires strong GMP knowledge, and application of risk-based processes.

Responsibilities

  • Supports project/program activities by performing work with an engineering specialty which involves various types of research, investigations, analysis and interpretation of data.
  • Analyzes nonconformances, complaints and trends to identify and recommend corrective and / or preventive actions.
  • Conducts investigation and analysis of issues as assigned.
  • May be assigned projects or investigations.
  • Develops, modifies, applies and maintains methods and procedures for product development, process control, testing and inspection to ensure the manufacturing of safe and effective biotechnological products.
  • Informs management on the status of assigned projects through the submission of reports on technical specifications, test results, equipment performance, etc.
  • May represent the company with customers and vendors in resolving technical issues.
  • May provide leadership and participate in the training of lower level personnel.
  • May assist in interpreting customer or marketing requirements.
  • Supports internal audit program as requested.

Additionally, this position may complete the following:

  • Works on moderately complex projects or assignments.
  • Conducts more in depth analysis, research as assigned.
  • Assists in the design review of new or modified products. Challenges process designs to ensure manufacturability, safety and effectiveness of products.
  • Develops and delivers training materials as requested.
  • Supports product improvement projects and supplier changes to ensure validation requirements are met.
  • Develops, reviews and challenges existing quality system procedures.
  • Collaborates cross functionally and with supplier representatives on quality issues and ensures corrective actions are implemented.
  • Identifies and analyzes actual and potential causes of risk, effects and control measures aimed at prevention and/or mitigation.
  • Develops and implements appropriate process monitoring and control methods consistent with the level of process/product risk.
  • Basic application of statistical tools and methods.
  • May approve basic to moderately complex investigations, corrective actions

Qualifications

  • Bachelor’s degree or equivalent in a related scientific discipline.
  • 0-2+ years experience or equivalent combination of education and experience.
  • Basic knowledge of Quality Engineering principles and theories.
  • Strong understanding of GMP / ISO regulations and validation principles preferred.
  • Efficient communication and strong interpersonal skills.
  • Ability to work well in fast paced and cross-functional teams.
  • Quality Engineering, Six Sigma Green Belt Certifications desirable.
  • Software Skills: MS Office Suite, SAP, Minitab (or similar, e.g.: JMP, SAS, R, etc.)
  • Skilled in statistical methods, statistical process control and experimental design preferred.
  • Basic understanding of risk management best practices and regulations for the medical device industry.

 

Vaccination Requirement: 

 

Due to the higher threat of more infectious and deadly COVID-19 variant strains emerging, Bio-Rad recently announced a new mandatory vaccination policy requiring its US employees to be fully vaccinated against COVID-19 as a condition of employment. Bio-Rad will make reasonable accommodations for valid exemptions based on disability, medical, or religious reasons. With this policy, Bio-Rad joins a growing list of companies that are prioritizing sound science and available facts to best ensure the ongoing safety of its employees and the community.

 

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.    #LI-PG1

 

 

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