Product Quality Specialist

2 weeks ago


Woodinville, Washington, United States AbD Serotec Full time

About the Role:

At Bio-Rad, we're seeking a skilled Quality Engineer I to join our team. This role is responsible for ensuring the quality of our products and processes.

Key Responsibilities:

  • Manage the Material Review Board (MRB) to ensure thorough data-driven documentation of non-conformities and risk-based determination of Corrective Action Preventative Action (CAPA).
  • Analyze trends in nonconformances and complaints to improve the overall efficiency of the Quality Management System (QMS).
  • Support the release of high-quality products by making risk-based and compliant decisions.
  • Maintain the integrity of the QMS by ensuring investigations are well-designed, executed, and documented.

Requirements:

  • Bachelor's degree or equivalent in a related scientific discipline.
  • Strong understanding of Good Manufacturing Practice (GMP)/ISO regulations and validation principles preferred.
  • Basic understanding of risk management best practices and regulations for the medical device industry.

Total Rewards Package:

Bio-Rad offers a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce.

Benefits:

  • Competitive medical plans for you and your family.
  • Paid parental leave.
  • 401(k) plus profit-sharing plan.
  • Employee stock purchase program.

Salary:

The estimated base salary range for this position is $67,725 to $86,200 per year, depending on experience and qualifications.



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