Senior Specialist Quality Assurance Professional

7 days ago

Santa Clara, California, United States Abbott Laboratories company Full time
About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our 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 Diagnostics Business

We are currently seeking a Senior Specialist Quality Assurance for our Diagnostics business. This role will be based in Santa Clara, CA.

Job Summary

The primary function of this position is to conduct quality-related activities to deliver consistent, high-quality documents, services, products, and processes.

Key Responsibilities
  • Defines project goals and milestones, ensuring timely project completion.
  • Provides solutions to a wide range of difficult problems, ensuring that solutions are compliant, innovative, thorough, practical, and consistent with organizational objectives.
  • Interacts effectively with employees, managers, and cross-functional peers, representing the team on cross-functional project teams.
  • Implements tactical solutions related to assignment, contributing functional skills and expertise broadly.
  • Directly influences project direction and scope, including one or more QA functions, with general knowledge of other related disciplines.
Quality System Compliance

Demonstrates a good understanding of the standards and regulatory bodies that regulate our industry, ensuring compliance to site-level policies and procedures.

Risk Management

Evaluates product safety and efficacy, elevating risk-based issues, and creates and reviews risk management documentation to reduce or eliminate risk.

Complaint Evaluation

Investigates complex complaints with little management oversight, providing solutions to a wide range of problems, ensuring compliant documentation in the area of responsibility.

Design Control / Documentation & Change Control

Formulates thorough reasons and justifications for change, identifying critical parameters associated with change.

Quality Engineering

Applies a solid understanding of quality system elements from product inception through launch, leading complex quality discussions across various departments, including external suppliers.

Validation

Acts as a Subject Matter Expert (SME) for at least one respective Validation Subsystem.

Requirements
  • Bachelor's degree in Life Science, Engineering, or a closely related discipline.
  • Minimum 5 years of experience in quality or a related field; less experience may be appropriate with an advanced degree.
  • Preferred experience in the Healthcare industry, with a history of completing successful projects and driving positive compliance outcomes.

Abbott is an Equal Opportunity Employer, committed to employee diversity. We offer a competitive salary range of $95,500.00 - $190,900.00, depending on location.

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