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Quality Engineer IV

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Quality Engineer IV

  • 2019-10069.1
  • Pleasanton, California, United States

Bio-Rad is a leader in the development of innovative droplet digital PCR systems.  Bio-Rad’s ddPCR systems represents a new era in reliability and affordability across a range of applications for life science researchers and molecular diagnostics developers.  Bio-Rad’s ddPCR systems 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 IV will be primarily responsible for actively participating in the Product Development/Design Control process of instruments and reagents for ddPCR products in the Research Use and IVD/FDA markets. In addition, this position requires owning the risk management process for new and legacy products as well as supporting other aspects of the Quality System.

 

A secondary responsibility will be working closely with the Lab Manager and have oversight of the equipment calibration process and PM program in compliance to ISO 13485 and FDA QSR’s.  It will include maintaining calibration/PM database.

 

This individual will be expected to provide hands-on leadership across a range of in vitro diagnostic devices. This will require project management skills, planning and on time completion of tasks, with strong hands-on technical capability. The position requires a self-starter individual, work in product development teams and capable of facilitating consensus solutions to complex Quality/Regulatory issues.

Responsibilities

This Quality Engineer IV will be primarily responsible for representing Quality Assurance interest in product development teams.  This area includes:

 

  • Partnering and working with peer level Quality Managers, Marketing and R&D staff to ensure the plans comply with ISO 13485 and FDA QSR’s.
  • Ensuring trace matrices from requirements to specifications to verification to validation to labeling are complete.
  • Partnering and working with subcontractor personnel to ensure appropriate production and Final QC testing is implemented.
  • Focus on reducing Out of Box Failure (OBF) and complaint rates.
  • Conduct audits of suppliers and other Bio-Rad facilities (domestic and international) to ensure they are properly qualified to provide products and/or services to Bio-Rad.
  • Lead risk management activities for new products and update risk files during the change control process as needed.

 

A secondary responsibility will be maintaining the equipment calibration and Preventative Maintenance program in compliance to ISO 13485 and FDA QSR’s.  This area includes:

 

  • Identifying all equipment requiring calibration or PM
  • Working with operations and lab personnel to assure equipment properly calibrated and/or PM.
  • Maintaining proper Cal/PM records and assuring corresponding database is up to date. 

Qualifications

  • System level V+V experience across instruments, chemistry and software
  • ISO 13485: 2016 (or latest version) Medical Device Quality Management System Requirements
  • ISO 14971: 2009 (or latest version) Risk Management
  • FDA 21 CFR part 820 Quality System Regulations
  • Current version In Vitro Diagnostic Directive (IVDD) a plus
  • Current version Medical Device Directive (MDD) a plus
  • Technical background that can be applied to hardware, software and chemical design/development.
  • Bachelor’s degree or equivalent in a related engineering discipline.
  • 8+ years’ experience or equivalent combination of education and experience working in an FDA and/or ISO 13485 regulated environment.
  • Advanced knowledge of and application of principles and theories of engineering.
  • Strong communication (including writing), technical, and computer skills.
  • Coordination, tact and team work.
  • Experience working with PCR and IVD’s a very big 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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