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Quality Systems Specialist III - $5,000 Hiring Bonus

Quality Systems Specialist III - $5,000 Hiring Bonus

  • 2022-29308
  • Hercules, California, United States

Bio-Rad is seeking a Quality Systems Specialist to join the Northern California QA team to perform customer case escalation management and investigation, along with supporting the CAPA, and Post-Market Surveillance processes.

 

This position is eligible for a $5,000 HIRING BONUS: 

 

  • Bonus offered for a limited time only.
  • Bonus applicable to specific positions as labeled.
  • Bonus recipients must be employed at the time of payout.
  • Bonus payout after 30 days of employment with Bio-Rad.
  • Bonus offered to direct hires only. Agency hires and internal transfers are not eligible.
  • 12 months repayment clause.

Responsibilities

  • Managing escalated customer complaint investigations in accordance with established company procedures and applicable standards.
  • Evaluate escalated complaint documentation for completeness and follow up with regional/global customer technical support teams if additional information is required.
  • Responsible for ensuring all required information for complaint file is obtained and properly documented.
  • Evaluating complaint file information to ensure appropriate analysis, investigation, and probable cause is documented prior to complaint closure.
  • Ensure adequate information is received to warrant timely reporting, investigation, and closure of product complaints.
  • Responsible for analyzing product quality information (case escalations, trend information, etc.) for potential escalation.
  • Provide technical and analytical support to subsidiaries and internal functional areas.
  • Perform preliminary evaluation and risk assessments on escalated complaints and escalate events that require additional investigation as necessary.
  • Works closely with R&D, Engineering, Manufacturing, and Facilities to resolve product and process quality issues.in support of the complaint management process.
  • Coordinate with internal stakeholders on risk assessments and hazard analysis as required.
  • Analyzes and prepares data for reports and recommendations for management reviews.
  • Acts as QA representative on project teams providing leadership and guidance on quality system related to the complaint management process or related processes.
  • Problem solving, decision making, time management, organization, communication, leadership, and computer skills.
  • Provides complaint process support during external audits or inspections.
  • Perform other quality systems duties (e.g. CAPA, Documentation Review, Training, etc.) as assigned.

Qualifications

  • Bachelor’s degree or equivalent in a related technical discipline with 5+ years’ experience or equivalent combination of education and experience.
  • Understanding of GMP and quality system standards as they apply to products manufactured by Bio-Rad.
  • Understanding of Medical Device/GMP/ISO regulations (ISO 14971, ISO 13485, MDSAP and FDA CFR Part 820), and FDA CFR Part 210/211 preferred.
  • Working knowledge of device/drug/biotech manufacturing processes including basic understanding of risk management regulations, principles, and application.
  • Problem solving, decision making, time management, organization, communication, leadership, and computer skills.
  • Excellent critical thinking, problem solving, coordination, teamwork, communication, technical and computer skills. SAP experience a plus.

 

Vaccination Requirement:

 

Due to the higher threat of more infectious and deadly COVID-19 variant strains emerging, Bio-Rad has a mandatory vaccination policy requiring its US employees to be fully vaccinated against COVID-19 as a condition of employment. New hires will be asked to upload their vaccination card into our electronic database hosted by ClearPass, who specializes in securing electronic medical information, within 3 days of their start date. 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.

#L1-PB1

 

 

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