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Quality Assurance Specialist

2 months ago


Alameda, California, United States Abbott Laboratories company Full time

About Abbott Laboratories

Abbott Laboratories is a leading global healthcare company that provides innovative solutions to help people live more fully at all stages of life. Our diverse portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.

Our Mission

At Abbott Laboratories, we are committed to delivering high-quality products and services that meet the evolving needs of our customers and patients. We strive to be a trusted partner in the healthcare industry, known for our integrity, innovation, and dedication to excellence.

The Opportunity

We are seeking a highly skilled Quality Assurance Specialist to join our team in the Diabetes Care division. As a Quality Assurance Specialist, you will play a critical role in ensuring that our products and processes meet the highest standards of quality and regulatory compliance.

Key Responsibilities

  • Lead and support internal and external audits to ensure compliance with regulatory requirements and industry standards.
  • Develop and implement quality management systems to ensure effective risk management and compliance.
  • Collaborate with cross-functional teams to identify and mitigate compliance risks and gaps.
  • Provide training and guidance to staff on quality and compliance procedures.
  • Monitor and report on compliance metrics and trends.
  • Participate in compliance initiatives and projects to drive continuous improvement.

Requirements

  • Bachelor's degree in a relevant field, such as quality assurance, regulatory affairs, or a related field.
  • 5+ years of experience in quality assurance, regulatory compliance, or a related field.
  • Excellent writing and communication skills.
  • Ability to work in a fast-paced, matrixed environment.
  • Strong analytical and problem-solving skills.
  • Lead Auditor Certification for ISO 13485 or 9001:2000 preferred.

What We Offer

At Abbott Laboratories, we offer a competitive compensation package, including a base salary of $73,600.00 - $147,200.00, depending on location. We also offer a comprehensive benefits package, including medical coverage, retirement savings plan, tuition reimbursement, and education benefits.