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Engineer I, QA

Company: Thermo Fisher Scientific Inc.
Location: Pleasanton
Posted on: April 27, 2021

Job Description:

Job Description Job Title QA Engineer 1 (Quality Assurance) Requisition ID: When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals. Location/Division Specific Information US - California - Pleasanton How will you make an impact? The role of the Quality Engineer is to support, strengthen and advance the Quality mission, which is enabling our customers to make the world healthier, cleaner and safer by continuously improving the quality of our products and services. The Quality Engineer will work with various team members and internal and external customers, with a high degree of professionalism. This is a very hands-on role and works collaboratively with other departments. What will you do? As a QA Engineer, you will help to ensure the Pleasanton site meets all the requirements for ISO 9001 and 13485. You will partner with colleagues, cross functional team members to support the QA dept through the following activities:

  • Archival of Training records and maintenance of Training system
  • Review daily complaint reports, partner with appropriate owners for resolution and investigation
  • Review complaint cases, use root cause analysis tools, identify root cause, draft investigation reports
  • Assist in audits as part of backroom support
  • Participate in Quality Improvement projects, Kaizens, JDIs, etc
  • Prepare & maintain team Quality metrics (e.g. past due reports, calculate turnaround time, etc)
  • Assist customers with Certificate (COA, COC, COO) requests
  • Review, write and revise Quality or Operation procedures and help with change control and implementation
  • Perform other duties to support the Quality department as assigned. How will you get here? * Bachelor's degree in life sciences, engineering, process engineering, chemistry, biotechnology or related sciences preferred
    • Experienced working in ISO 9001, 13485 and/or GMP environment
    • 1-2 years of work experience in Quality Assurance/Quality Control; manufacturing experience a plus
    • Experience reviewing production/manufacturing/quality records
    • Strong understanding of Good Documentation Practices
    • Computer skills (Office, Teams, Word, Excel) with experience in SAP, Agile and TrackWise preferred
    • Experience working & collaborating effectively cross-functionally Knowledge, Skills, Abilities
      • Must be self-motivated, proactive, organized, and very detail oriented
      • Solid organizational and time management skills to meet deadlines
      • Highly energetic, positive attitude, and works well under stress
      • Excellent communication and interpersonal skills with the ability to interact with all levels of the organization Ability to work in teams and independently to obtain results

Keywords: Thermo Fisher Scientific Inc., Pleasanton , Engineer I, QA, Engineering , Pleasanton, California

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