Quality Engineer I at Thermo Fisher Scientific | Austin, TX, US | Rezi

Quality Engineer I at Thermo Fisher Scientific

Quality Engineer I

Thermo Fisher Scientific · Austin, TX, US

2 weeks ago

Quality Engineer I

Thermo Fisher Scientific · Austin, TX, US

19 days ago
Resume preview

Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Responsibilities

  • Perform incoming inspection of raw materials, components, and finished goods to ensure compliance with established quality standards and specifications.
  • Review and approve manufacturing batch records for completeness, accuracy, and compliance with cGMP, USDA, and applicable regulatory requirements.
  • Conduct pre-pack and post-pack inspections for USDA and other regulated SKUs to verify product quality, labeling, and packaging compliance.
  • Coordinate Nonconforming Material (NCM) and deviation records related to assigned quality activities, ensuring timely documentation, investigation, and resolution.
  • Support quality investigations, root cause analysis, and CAPA activities to address nonconformances and drive continuous improvement.
  • Maintain accurate quality documentation in accordance with Quality Management System (QMS) requirements and applicable regulations.
  • Partner with Manufacturing, Supply Chain, Warehouse, Engineering, and Regulatory teams to resolve quality issues and support product release.
  • Participate in internal audits, regulatory inspections, and continuous improvement initiatives to strengthen quality systems and ensure compliance.
  • Perform other quality-related duties as assigned.

Requirements

  • Must be legally authorized to work in the United States without sponsorship.
  • Must be able to pass a comprehensive background check, which includes a drug screen.
  • Must be able to work in controlled manufacturing environments while wearing required PPE.

Skills

  • Working knowledge of cGMP, ISO 13485/9001, and quality system requirements.
  • Familiarity with quality processes including incoming inspection, batch record review, nonconforming materials (NCM), deviations, CAPA, and SOPs.
  • Experience with quality management systems (e.g., TrackWise, SAP) and Microsoft Office applications preferred.
  • Strong analytical, organizational, and problem-solving skills with excellent attention to detail.
  • Effective written and verbal communication skills.
  • Ability to collaborate across cross-functional teams.
  • Ability to manage multiple priorities in a fast-paced, regulated manufacturing environment.
  • Experience with Lean, Six Sigma, or continuous improvement methodologies preferred.

Location

  • Austin, TX

Work Type

  • Standard (Mon-Fri)
  • Office
  • Warehouse
  • Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Experience Level

  • No prior experience required

Education Level

  • Bachelor's degree required

Benefits

  • Competitive remuneration
  • Annual incentive plan bonus
  • Healthcare
  • Range of employee benefits

About the Company

  • Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.
  • We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!