The Quality Engineer III will support the Quality Manager in ensuring the Quality Management System and quality standards of the company are implemented and maintained at the facility in accordance with corporate quality policies, applicable regulatory requirements, ISO requirements, and customer specifications/expectations. The QE III will serve as a delegate to the Quality Manager. Position will lead complaint investigations, NMR investigations, Supplier Corrective Action investigations, CAPA investigations, and drive continuous improvement projects throughout the plant. Position will lead or support for Engineering Changes, Gage R&R, or validations required to support existing/new processes.

Utilize specialized technical knowledge to develop, process, and test materials used in a variety of products. Recommend materials with specific characteristics appropriate for use in a particular application. Support regulatory requirements for life sciences for internal and external requests. Ensure material compliance to meet USP Class VI, NSF, EP 3.1.0, and ISO 10993 specifications.

Conduct projects on silicone polymer processing to support manufacturing engineering, thereby building technical depth in the polymer area. Collaboratively work with R&D Group as directed by the site, participate in identifying potential projects that support manufacturing research efforts. Develop projects plans, direct and coordinates the implementation of approved plans through indirect reports. Provide personal technical input and employ strong scientific methodology in conducting projects. Respond to changing priorities as required. Identify potentially patentable development proprietary technologies resulting in patents. Integrate scientific knowledge of polymers (structure, chemistry, & properties) with knowledge of equipment & process to develop deeper understanding of silicone polymer behavior during processing. Integrate the scientific tools to explore process/material combinations for optimal processing conditions.

Job functions:

Support the development, implementation, and oversight of an effective QMS that operates in compliance with corporate quality polices and procedures, and relevant regulatory requirements and industry guidance, including:

Document control and review/approval of controlled documents

Change management and review of change controls

Investigation and CAPA management, including robust root cause analysis

Complaint management and performance of complaint investigations

Supplier quality management and performance of supplier audits as appropriate

Internal audit program and performance of internal audits

Training program

Implementation of Quality Risk Management in relevant aspects of the QMS

Management Review

ISO certification and maintenance

Lead and/or support the oversight of product realization and commercial manufacturing activities, such as product/specification development, tech transfer, validation, process capability, facilities/utilities/equipment qualification and maintenance, and materials management. Support the testing, review, and disposition process for production batches and incoming raw materials, including management of deviations and nonconforming product.

Customer support:

Support customer audits

Partner in the resolution of quality issues and customer requests