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Quality Mgr II

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Quality Mgr II

  • 2020-16443
  • Irvine, California, United States

QA Manager I position with 6 direct reports located in Irvine, CA.

Responsibilities

Responsible for:

 

A team of Quality Engineers supporting the site risk management program and the technical review process (updating processes, specifications, and procedures based on QMS feedback. This position includes overseeing creating, updating and managing product and process risk files, including leading or participating on cross functional teams during design control, change management, new product introduction and CAPA activities. You will also be leading the development and sustainability processes for the management of risk (ISO 14971), usability (ISO 62366) activities during various design control phases through post market surveillance, and complaint investigations, including, but not limited to:

  • Creation of internal procedures, development and deployment of training material related to these activities.
  • Responsibility for the development and maintenance of Quality Analytics related to the overall performance of the Quality Management System, with an emphasis on post market product performance

Qualifications

  • Bachelor’s degree or equivalent in a related field.
  • 8+ years relevant quality systems experience with supervisory experience, or equivalent combination of education and experience.
  • Experience working in a regulated environment.
  • Experience supervising/managing a quality systems program in a regulated environment a plus.
  • Experience with managing product and process risk files a plus.
  • ISO auditor certification desirable. Quality Engineer, Quality Manager, Six Sigma Green or Black Belt Certification desirable.
  • Excellent written, verbal and presentation skills, including the ability to persuade others with fact-based arguments. Good organizational skills, including the ability to manage multiple projects simultaneously, with follow-through and ability to meet defined deadlines.
  • Strong interpersonal skills are necessary to operate in a team environment to interact with multiple departments under a variety of conditions.
  • Customer orientation and focus.
  • Working knowledge of the device/drug/biotech manufacturing process.
  • Experience with risk management regulations and application.
  • Experience as a GMP and/or ISO trainer is highly desirable.
  • Understanding of 21 CFR 820 and ISO standards as they apply to products manufactured by Bio-Rad.
  • Experience with MDSAP requirements and/or MDSAP training preffered.
  • Experience with IVDR requirements and/or IVDR training preffered.
  • Experience with SAP ERP System preffered.

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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