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Quality Manager I

Quality Manager I

  • 2021-25872
  • Hercules, California, United States

Bio-Rad is seeking a Quality Manager to join the Northern California QA team to support the Complaint Management System overseeing multiple manufacturing units. The Quality Manager will oversee a team of 3 to 4 Quality Engineers and Quality System Specialists responsible for ensuring the effective and timely management of customer case escalations, complaint investigations, vigilance and post market surveillance activities.

Responsibilities

  • Provide day to day supervision and management including, but not limited to, distribution of team workload, employee development and training.
  • Ensure complaint escalations and complaint investigations are received, reviewed, investigated and closed in accordance with Bio-Rad procedures and required regulatory requirements (FDA 820, MDSAP, ISO 13485).
  • Provide SME guidance and support for stakeholders, including product Legal Manufacturer R&D and Product Support teams, Global Commercial Operations Technical Support teams, Manufacturing operations, and QA Operations.
  • Maintain, improve, and develop internal processes to increase efficiency of case management activities. This includes creation, revision, and approval of applicable procedures, process flow maps, and product/process risk files. Oversee the management of various Complaint Review Board meetings including stakeholder coordination and action item follow through.
  • Prepare and present departmental and system performance metrics at various levels of the management review program, as required. This includes the analysis of quality data while applying statistical techniques to ensure that recommendations for the initiation of new investigations and/or CAPA activities are based on valid statistical methods.
  • Work effectively with all levels of management to ensure case investigations and requests as well as CAPA action plans can be supported and that resources needed to implement the plan are available.
  • Facilitate post-market Risk Management activities such as updating risk management files and compiling post-market surveillance reports.
  • Create and improve QMS procedures and training materials as required. Support other quality and compliance activities as required including supporting audits and inspections. Ability to make timely and effective decisions in a fast paced and sometimes stressful environment while helping to foster a quality-driven mindset throughout the business.
  • Other duties as assigned.

Qualifications

  • Bachelor’s degree or equivalent in a scientific or engineering discipline.
  • 5+ years’ relevant quality systems experience with supervisory experience, or equivalent combination of education and experience.
  • Experience working in the in a medical device, pharmaceutical or other regulated industry. Working knowledge of medical device/drug/biotech manufacturing process and experience with risk management regulations and standards, including FDA 21 CFR 820, MDSAP, IVDR, ISO 13485 and ISO 14971.
  • Experience as a GMP and/or ISO trainer is highly desirable.
  • Experience working in a global organization and/or interfacing with multiple manufacturing locations a plus.
  • Quality Engineer, Quality Manager, Six Sigma Green Belt or Black Belt desirable.
  • Communication, public speaking, decision-making under stressful conditions, word processing, and spreadsheet and negation skills required.
  • Customer oriented and focused.

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.

 

 

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