Supplier Raw Material Quality Engineer

Work Schedule

Standard (Mon-Fri)

Office

Location:

Grand Island, NY. 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 screening.

At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Our colleagues bring the company’s mission to life every day, enabling customers to make the world healthier, cleaner, and safer. As part of the Biological and Chemicals Division (BCD), this role supports the supply base that provides critical materials used in life science products.

This position is based at the Grand Island, NY site and supports supplier quality activities across the BCD supply base. The Raw Material Quality Engineer partners with Procurement, Manufacturing, Planning and Quality teams to ensure supplier quality, compliance, reduce cost of poor quality, and capability.

The role manages quality performance for suppliers providing raw materials, reagents, and critical manufacturing components. Responsibilities include supplier qualification, investigation of nonconformances, and supplier development initiatives that strengthen supply chain reliability.

• Lead investigation and resolution of supplier-related nonconformances.
• Drive supplier corrective actions using structured problem-solving methods such as 8D or DMAIC.
• Collaborate with Procurement, Manufacturing, and Quality teams to address supplier risks.
• Analyze supplier performance metrics and identify improvement opportunities.
• Support supplier qualification, onboarding, and change management processes.

• Reduction of supplier-related nonconformances
• Improved supplier performance metrics
• Effective closure of supplier corrective actions
• Reduction of supplier-driven cost of poor quality

• Bachelor’s degree required in Life Sciences, Chemistry or related scientific/technical field

• Minimum 3-5 years of quality assurance, quality control, or supplier quality experience in GMP/ISO regulated manufacturing environments, preferably in medical devices, pharmaceuticals or biotechnology industries
• Experience working within ISO 13485 and/or 21 CFR Part 820 or GMP-regulated industries preferred
• Experience leading or supporting investigations, root cause analysis, and corrective and preventative action (CAPA) activities

• Strong knowledge of quality systems, cGMP regulations, and standards including ISO 13485, 21 CFR Part 820
• Expertise in quality tools and methodologies including risk management, root cause analysis, CAPA, statistical analysis tools, quality metrics reporting and change control
• Demonstrated experience leading investigations, analyzing quality data, and implementing effective corrective actions
• Excellent documentation and technical writing skills for developing SOPs, protocols and reports
• Strong proficiency in quality management software (Track Wise, SQP QM) and Microsoft Office suite
• Demonstrated ability to build consensus and collaborate across functions
• Ability to manage multiple investigations, supplier actions, and completion of priorities within a fast-paced environment.
• Ability to work independently while contributing effectively in team environments
• Strong attention to detail with analytical and problem-solving capabilities
• Strong verbal and written communication skills
• Project management skills and ability to prioritize effectively
• Ability to work in clean room environments when required

Periodic visits to supplier manufacturing facilities and internal production areas may be required.

Appropriate PPE including cleanroom garments may be necessary depending on the environment.

Thermo Fisher Scientific offers competitive compensation, annual incentive plans, healthcare, benefits, pension contributions, and a comprehensive range of employee benefits. The organization provides strong opportunities for professional development and career growth.

The…