Quality Assurance Specialist

2 days ago


Rochester, New York, United States Quidel Corporation Full time
Job Overview

Quidel Corporation is a leading in vitro diagnostics company with a strong presence globally. We are seeking a Quality Assurance Specialist to join our team in Rochester, NY. This role will provide quality engineering support to Quality and Operations staff on all aspects of the manufacturing process.

Key Responsibilities:
  • Partner with operations to evaluate and address quality events including nonconformance, product dispositions, root cause investigations, and implement appropriate CAPA based on risk level.
  • Analyze and monitor key quality metrics and develop action plans to address unfavorable trends.
  • Promote continuous improvement activities by seeking out opportunities to optimize processes and systems to reduce variation and improve product quality.
  • Drive implementation of best practices to eliminate repeat quality events and improve product quality.
  • Support product and process root cause investigations by collaborating with product support, engineering, and operations.
  • Support and participate in inspection readiness activities by applying working knowledge of ISO13485 and 21CFR Part 820 regulations.
  • Provide coaching, training, and technical guidance to business partners in aspects of the company quality system requirements as they pertain to manufacturing quality and provide guidance of effectively applying key quality engineering principles and tools.

Requirements:
  • B.S. Degree in Chemistry, Biochemistry, Biology, Engineering, or a related discipline.
  • 3-5 years of experience in Quality in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical, or Consumer).
  • Advanced Microsoft Office tools experience for communications, reporting and data analysis is required.

Estimated Salary Range: $65,000 - $85,000

About Quidel Corporation:
At Quidel Corporation, we put our team members first and prioritize actions that support happiness, inspiration, and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked.

The Work Environment:
This position will be onsite full-time at our Rochester, NY office. You will need to support a morning shift, Monday-Friday. The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples.

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