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Medical Device Quality Engineer

Thermo Fisher Scientific
Grand Island, NY Full Time
POSTED ON 1/31/2025
AVAILABLE BEFORE 3/1/2025
Job Overview
Thermo Fisher Scientific is seeking a highly skilled Medical Device Quality Engineer to join our team. As a key member of our quality department, you will be responsible for ensuring the highest level of quality in our medical devices and processes. This role involves working closely with cross-functional teams to develop and implement quality management systems, as well as collaborating with customers and regulatory agencies to resolve quality-related issues.

Salary Range
The salary range for this position is $60,000-$90,000 based on location and experience.

About the Role
In this role, you will have the opportunity to work on a wide range of quality-related projects, from developing quality management systems to resolving customer complaints. You will also have the chance to collaborate with a talented team of professionals who are passionate about delivering high-quality products and services.

Key Responsibilities
  • Draft, review, and finalize Quality Agreements and Change Notifications with customers.
  • Support and handle change management and notification activities relating to BCD business processes.
  • Collaborate across functions to support development and implementation of Divisional QMS policies and procedures.
  • Participate in multi-functional projects of moderate scope to support the BCD Quality Management System.

Required Skills and Qualifications
  • Bachelor's degree in a Science field or relevant quality experience.
  • Familiarity with quality standards such as 21 CFR Part 820, ISO 13485, ISO 9001.
  • Experience with US Pharmacopoeia, European Pharmacopoeia, Japanese Pharmacopoeia, and British Pharmacopoeia testing would be beneficial.

Salary : $60,000 - $90,000

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