Supplier Raw Material Quality Engineer

Thermo Fisher Scientific•Grand Island, NY

8d•Hybrid

About The Position

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.

Requirements

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 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 (TrackWise, 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

Nice To Haves

Experience working within ISO 13485 and/or 21 CFR Part 820 or GMP-regulated industries preferred

Responsibilities

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.

Benefits

Competitive compensation
Annual incentive plans
Healthcare
Benefits
Pension contributions
Comprehensive range of employee benefits
Strong opportunities for professional development and career growth
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO)
10 paid holidays annually
Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave)
Accident and life insurance
Short- and long-term disability
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP)