Senior Raw Material Scientist: Qualification & Quality Lead

cGMP Consulting Inc.; Chicago (IL); On-site; USD 110,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Paid time off

401K

Job summary

cGMP Consulting is seeking a detail-oriented professional to lead technical evaluations and qualification of raw materials for medical devices. You will review testing specifications, assess supplier documentation, and establish acceptance criteria to ensure materials meet product and regulatory requirements.

You will collaborate with R&D, analytical sciences, quality, procurement, and manufacturing to support material qualification, change control, and investigations, ensuring consistent

Qualifications

• MS/MTech in a related field is required.
• 5–8 years in raw material characterization or qualification.
• Experience reviewing supplier CoAs and technical data sheets.
• Familiarity with ISO 13485, ISO 14971, ISO 10993 and related standards.
• Experience with material equivalence assessments and supplier changes.

Responsibilities

• Develop raw material testing specifications and acceptance criteria.
• Review and optimize purchasing specifications to align with product requirements.
• Analyze CoAs, SDS, and other documentation for material compliance.
• Characterize materials using FTIR, DSC, TGA, and other techniques.
• Establish scientifically justified acceptance limits based on data and risk.
• Collaborate with R&D, QA, procurement, and manufacturing.
• Prepare material evaluation reports and qualification documentation.

Skills

Materials characterization

Analytical testing

Regulatory compliance

Cross-functional collaboration

Education

M.S. or M.Tech in Materials Science and Engineering

B.E./B.Tech with experience

Tools

FTIR

DSC

TGA

GPC/SEC

Moisture analysis

Job description

cGMP Consulting is seeking a detail-oriented professional to lead technical evaluations and qualification of raw materials for medical devices. You will review testing specifications, assess supplier documentation, and establish acceptance criteria to ensure materials meet product and regulatory requirements.

You will collaborate with R&D, analytical sciences, quality, procurement, and manufacturing to support material qualification, change control, and investigations, ensuring consistent