Quality Engineer: Fixed Term
Quality Engineer: Fixed Term
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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 Bachelors or Masters 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 companys 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.
Employment Type
Full-Time
