Quality Engineer I

Thermo Fisher Scientific · Austin, Texas, USA · 2 months ago

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Category: Industrial engineering
Experience: 0+ years

iso-13485 personal-protective-equipment regulatory-compliance root-cause-analysis sap six-sigma

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

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

Job Description

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.

Location/Division-Specific Information:

Austin, TX. Relocation assistance is NOT provided.

*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.

Discover Impactful Work:

At Thermo Fisher Scientific, you'll join a quality assurance team focused on ensuring consistent execution of quality standards and regulatory compliance. You'll play a vital role in enabling our customers to make breakthrough discoveries and innovations that make the world healthier, cleaner and safer. You'll ensure product quality, drive continuous improvement initiatives, and collaborate with cross-functional teams to maintain the highest standards of quality and compliance in a GMP environment.

A Day in the Life:

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 (batch binders) 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.

Keys to Success:

Education and Experience

Bachelor's degree required; no prior experience required. Experience in the pharmaceutical, biotechnology, medical device, food manufacturing, or other regulated industries preferred.
Preferred fields of study: Chemistry, Biology, Biotechnology, Engineering, or related scientific/technical discipline.
Working knowledge of cGMP, ISO 13485/9001, and quality system requirements; USDA-regulated manufacturing experience preferred.
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 and the 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.
May require up to 10% travel.
Must be able to work in controlled manufacturing environments while wearing required PPE.

Benefits:

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. 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!

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