Thermo Fisher Scientific Quality Assurance Engineer in Carlsbad, California

Job Description

Job Summary:

The Quality Assurance Engineer will be responsible for driving the execution of quality goals and objectives. This position will proactively drive actions to meet internal and external customer expectations for quality. This position will work with internal departments including Production & Distribution to identify causes of potential product/process failures and drive corrective and preventative actions internally and/or with suppliers as needed.

Key Responsibilities:

  • Assist with the maintenance of ISO registration and the internal audit program

  • Participate in change control activities for documents and manufacturing processes

  • Collaborate across function, leveraging others’ quality and manufacturing expertise to troubleshoot problems, interpret data, and determine next steps

  • Be a partner for the manufacturing and distribution work areas

  • Provide guidance and direction to ensure ISO/Quality system compliance

  • Ensure accuracy and regular updates of documents

  • Ensure proper use of quality systems and processes

  • Manage problem requests, complaint records, and corrective and preventive actions

  • Manage customer complaints, including trending and problem solving

  • Manage maintenance, completeness, and accuracy of Quality records

  • May provide guidance or direction to other lower-level personnel such as assistance with prioritization and investigations

  • Investigate quality problems

  • Perform training on Quality procedures

  • Create, review and revise quality policies and procedures

  • Collect and analyze quality data

  • Participate, as needed, on new product teams

  • Perform all job duties in a safe manner and obeys all safety policies and procedures

  • Perform all job duties consistent with the Code of Ethics and the 4-I values

  • Perform all job duties within ISO standards, regulatory or statutory requirements

  • Perform other duties and cross training as assigned

Minimum Requirements/Qualifications:

  • Bachelors degree in a scientific discipline preferred

  • 1-5 years experience in a manufacturing or quality environment

  • High level of proficiency in Excel

  • Knowledge in standards and regulations such as ISO 9001

  • Strong written and oral communication skills

  • Must be able to communicate effectively with multiple levels of staff throughout the organization

  • Possess strong organizational skills with the ability to manage and prioritize multiple tasks and meet deadlines

  • Detail-oriented and accurate

  • Employee must be self-motivated with the ability to work as a team player and/or independently

  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions

  • Normally receives minimal instruction on routine work and general instructions on new assignments

  • Customer focused

  • Ability to effectively communicate requirements without alienating audience

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.