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Risk Quality Engineer III

Risk Quality Engineer III

  • 2021-24044
  • Hercules, California, United States

Bio-Rad is seeking an experienced Quality Engineer to join the Northern California Quality Assurance team to support post market surveillance activities, CAPA and complaint investigations, risk management file creation & updates and support of new product development.

 

The Quality Engineer will play a key role in supporting the Risk Management, Post Market Surveillance, complaint and CAPA programs for numerous Life Science (LSG) and Clinical Diagnostics (CDG) products. 

Responsibilities

  • Manage the Risk Management and Post Market Surveillance Board including the facilitation of regular meetings, management of annual reporting cycles and review and approval of risk and post market surveillance plans/reports.
  • Establishing a strategy and step by step approach for Risk Management and related Technical File documentation to ensure compliance with EU IVDR, ISO 14971:2019 and IEC 62366-1:2015 requirements. Also leading and overseeing a risk-based work plan to accomplish the strategy within fixed project schedules.
  • 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.
  • Contributing to and/or reviewing health hazard analyses and product risk assessments for issues potentially impacting patient outcomes.
  • Assessing technical product and QMS documentation such as test protocols, reports, manufacturing procedures, complaints, instances of nonconformance, CAPA, change orders, etc.
  • Assess and update, as required, product risk management files related to the change control, manufacturing process control, design control, complaint and CAPA programs.
  • Mentoring peers and lower level Quality Engineers in the application of Risk Management and Post market Surveillance requirements and industry best practices.
  • Assisting RAQA leadership with communication of Risk Management and Post Market Surveillance program status and needs to executive management team members.
  • 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 regulatory submissions, audits and inspections.
  • Support, manage and/or lead CAPA and complaint investigations as required.
  • Help to drive and foster a quality environment and mindset throughout the business.

Qualifications

  • Bachelor’s degree or equivalent in Biology, Chemistry, or related field.
  • 5+ years’ experience in a regulated manufacturing industry or equivalent combination of education and experience.
  • Full knowledge of and application of Quality Engineering and Risk Management required.
  • Thorough understanding of GMP/ISO regulations (ISO 14971, ISO 13485, IEC 62366, MDSAP, IVDR and FDA 820/210/211).
  • 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 experiences, Six Sigma Green or Black Belt certification 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. #LI-AK1

 

 

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