NPI Supplier Quality Engineer
Qualification: Bachelor's Degree
- Supplier Monitoring: Track Supplier performance metrics and trends to assist in supply base improvement. Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
- Providing inputs in the design transfer or manufacturing transfers for New Product Introduction(NPI) to other sites or supplier locations.
- Responsible for the transfer of Class III medical devices to production and market release following the FDA Quality System Regulation, GLP, GMP Guidelines, Medical Device Directive, ISO 13485, and other international regulatory requirements.
- Setting up design and development process as per 21 CFR 820.30 & ISO13485 requirements.
- Supporting product launch and phase review processes – design reviews, product risk management, maintenance of DHF and review of documentation and Technical Files.
- Be results-oriented and have the ability to complete deliverables against Project deadlines.
- Able to communicate effectively both orally and in written form to multiple levels of the company.
- Demonstrates characteristics of high potential for future development opportunities.
- Proficient with Microsoft Office Suite Applications.
- Supplier Selection & Evaluation: Perform Supplier Quality system assessments for risk and opportunity. Support Supplier selection process and technical reviews.
- Supplier Product Quality: Work with Suppliers through the supplier launch process and perform Production Part Approval / Sample submission reviews. Utilize AIAG methods as a model for PFMEA, Control Plan, MSA/Gauge R&R, and related requirements throughout the process.
- Ability to conduct Process Validation using IQ/OQ/PQ as per 21 CFR 820.75.
- Problem Solving: Assist the problem solving process to identify and resolve root cause(s) of nonconformities. Issue Corrective and Preventive Actions (CAPA) to suppliers.
- Manage containment, follow- up and establish robust CAPAs while driving issues to permanent resolution. Utilize structured problem solving and Lean/Six-Sigma methodologies throughout the process.
- Knowledge of blueprint reading and geometric dimensioning & tolerancing, understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and the ability to use inspection, measurement and test equipment, such as hand gauges, optical comparators and CMMs.
Bachelor’s degree required in Chemical Engineering or closely related field.