Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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.

DESCRIPTION:

Join our team as a Supplier Quality Engineer at Thermo Fisher Scientific, where you'll contribute to global healthcare and scientific innovation. In this role, you'll be instrumental in driving improvements and reducing risks across our supply chain while ensuring the highest quality standards for our products. Working closely with suppliers and cross-functional teams, you'll qualify new suppliers, analyze and enhance supplier performance, and implement quality improvement initiatives.

As a member of our Quality team, you'll conduct supplier audits, manage corrective actions, and ensure compliance with regulatory requirements. You'll collaborate with Procurement, R&D, and Operations teams to develop and improve quality assurance methodologies. Your work will contribute to our mission of enabling customers to make the world healthier, cleaner, and safer through robust supplier quality management.

REQUIREMENTS:

• Bachelor's Degree or equivalent plus 5 years of experience in supplier quality in medical devices, pharmaceutical, or related regulated industry highly preferred.
• Preferred Fields of Study: Engineering, Science, Biological Sciences, Chemistry, or related field
• ISO 13485 and/or ISO 9001 Internal Auditor certification preferred
• Lean Six Sigma Green or Black Belt certification preferred
• Strong working knowledge of FDA regulations (21 CFR Parts 210, 211, 600), EU GMP, and ICH guidelines
• Experience with supplier qualification, risk assessments, audits, and ongoing supplier oversight
• Ability to lead through influence and collaboration without direct authority
• Proficiency with Quality Management Systems (QMS) and Microsoft Office tools
• Strong problem-solving and root cause analysis skills
• Effective written and verbal communication skills
• Ability to manage multiple priorities in a fast-paced GMP environment

Preferred Qualifications

• Experience in aseptic filling, sterile manufacturing, or biologic drug products
• Experience supporting regulatory inspections or client audits
• Experience with supplier audits and external vendor management
• Demonstrated experience working cross-functionally
• Knowledge of cold chain management or temperature-sensitive materials
• Familiarity with SAP or other ERP systems
• ASQ certifications (CQE, CQA) or Lean/Six Sigma certification

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!

OTHER

• Relocation assistance is not provided.
• Must be legally authorized to work in the United States now and in the future, without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening.