Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Position Objective:
We are recruiting for a fixed term Quality Engineer. Join Thermo Fisher Scientific Inc. as a Quality Engineer II and contribute significantly to maintaining high-quality Systems in line with ISO13485 and FDA 21CFR Part 820. Your duties involve ensuring compliance with internal and external standards, leading data analysis, investigations, and enhancing processes for improved results.
Essential Functions:
* Collaborate closely with Production, Technical, and Manufacturing Engineering teams to resolve quality issues from customer complaints and internal incidents. You will facilitate investigations and resolutions of these related quality issues.
* Partner with technical support and manufacturing to develop and refine methods and procedures, ensuring processes, products, tests, materials, and manufacturing equipment meet required standards.
* Aim to improve efficiency in procedures and processes without compromising quality. Identify and implement improvement opportunities across the operational facility.
* Perform statistical analysis to determine trends, conduct root cause analysis, and lead corrective actions for processes and products.
* Stay Informed of Regulatory and Quality System requirements (ISO13485/FDA CFR).
* Apply the Trackwise system for managing non-conformances, deviations, and Corrective and Preventative Actions (CAPA).
* Apply the Agile system for change controls, providing training, support, and facilitation within operations.
* Participate on the Internal Quality Audit team.
* Maintain adherence to internal and external guidelines like GMPs and ISO regulations, and authorise resolutions for non-compliances related to raw materials and final products.
* Provide training and support to other QA staff as needed.
* Operate independently without continual direction, exercising considerable latitude in determining technical objectives and solutions to complex problems.
* Perform other related duties as required or assigned.
Education:
A Bachelor's or Master's degree in chemistry, biochemistry, microbiology, engineering, or a related field is required.
Experience:
* Relevant quality experience with a proven understanding of compliance, quality, and scientific principles is necessary.
* Proficiency in Six Sigma tools and methodology is vital.
* Strong oral and written communication skills, with the ability to work effectively in a cross-functional team environment, are a must.
* You must be a self-starter who can take general concepts and direction and produce outstanding results, functioning effectively in a global, multi-site organization.
Contacts:
You will collaborate closely with all other departments on matters concerning quality and service to maintain the company's dedication to customer happiness. This includes partnering with individuals at every level within the organization, as well as external customers and regulatory bodies.
Working Conditions:
Primarily office-based, with some time spent in manufacturing and warehouse environments.