Position SummarycGMP Consulting is seeking a motivated and detail-oriented individual to lead technical evaluations, characterization, and qualification of raw materials used in medical devices, including polymers, elastomers, metals, coatings, and other functional materials. This individual will evaluate raw material testing specifications, review purchasing specifications, assess supplier documentation, and establish scientifically justified acceptance criteria to ensure materials meet product, quality and regulatory requirements.
The ideal candidate will work closely with R&D, analytical sciences, quality, procurement, supplier quality, and manufacturing teams. They will also support material qualification, change control, and investigations to ensure consistent material quality and reliable medical device manufacturing. This candidate should have a strong understanding of current Good Manufacturing Practices (cGMP) and FDA regulations and guidelines.
Responsibilities The essential functions include, but are not limited to the following:
- Evaluate and develop raw material testing specifications, including test parameters, analytical methods, sampling requirements, and acceptance criteria.
- Review and optimize raw material purchasing specifications to ensure alignment with product requirements, supplier specifications, and internal quality standards.
- Analyze supplier technical data sheets, Certificates of Analysis (CoAs), safety data sheets, and other relevant technical documentation to assess material compliance.
- Characterize raw materials using appropriate analytical techniques, such as FTIR, DSC, TGA, GPC/SEC, rheology, moisture analysis, chromatography, and mechanical testing, as applicable.
- Establish scientifically justified acceptance limits based on material properties, historical data, supplier capabilities, product requirements, and risk assessments.
- Evaluate new materials, alternate grades, and supplier changes through comparative analysis and material equivalence assessments.
- Investigate material variability, out-of-specification results, contamination, and material-related manufacturing or product performance issues.
- Support raw material qualification, supplier approval, incoming inspection optimization, change control, and nonconformance investigations.
- Assess the impact of raw material properties on medical device functionality, processability, biocompatibility, sterilization compatibility, and product reliability, as applicable.
- Collaborate with R&D, analytical sciences, quality, procurement, and manufacturing teams to resolve material-related technical challenges.
- Prepare material evaluation reports, specification justifications, qualification protocols, and technical documentation in accordance with applicable quality-system requirements.
- Identify opportunities to improve raw material quality, strengthen supplier controls, and optimize material testing requirements.
- Perform additional tasks or duties as assigned by management.
Requirements - M.S or M.Tech in Materials Science and Engineering, Polymer Science, Chemistry, Analytical Chemistry, Chemical Engineering, Biomedical Engineering, or a related discipline.
- A B.E/B.Tech degree in a relevant discipline may also be considered with suitable industry experience.
- 5-8 years of relevant experience in raw material characterization, analytical testing, material qualification, or specification development, preferably in the medical device, pharmaceutical, healthcare, or regulated manufacturing industry.
- Hands-on experience evaluating raw material testing specifications, acceptance criteria, and purchasing specifications.
- Experience reviewing supplier CoAs, technical data sheets, and material compliance documentation.
- Practical knowledge of analytical techniques for polymer, elastomer, metal, coating, or other functional material characterization.
- Experience with material equivalence assessments, supplier changes, root-cause investigations, and material-related quality issues.
- Familiarity with quality systems, change controls, risk assessments, and technical
- Familiar with ISO 13485, ISO 14971, ISO 10993, and relevant ASTM, ISO, or USP standards, as applicable.
Compensation and Benefits - Expected pay range per year: $110,000-$130,000 USD
- Expected benefits include: Medical, Dental, Vision, PTO, 401K
Disclaimer The duties and responsibilities described are not a comprehensive list and additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands. All duties and responsibilities are subject to possible modification to reasonably accommodate individuals with disabilities. The requirements listed are the minimum levels of knowledge, skills, or abilities necessary to perform this job successfully.
