Develop and refine global design controls, process development, and risk management quality system policies and procedures for new product development.
We are seeking an experienced professional to lead the development of effective solutions that meet global needs. The ideal candidate will have a strong background in engineering or science, with experience developing and managing policies and procedures.
The successful candidate will work across global research and development, quality systems, and functional stakeholders to develop and implement global policies and procedures for design controls, process development, and risk management.
Key responsibilities will include:
* Developing and maintaining an understanding of applicable standards, regulations, and guidance documents
* Coordinating implementation of global policies and procedures with local sites and global research and development operations design assurance personnel
* Supporting other companies as needed to implement global quality system policies and procedures
The ideal candidate will have excellent problem-solving skills, effective oral and written communication skills, and the ability to work in collaborative and independent environments with minimal supervision.
A bachelor's degree in engineering or science is required, preferably in mechanical, chemical, manufacturing, or biomedical disciplines. At least 5 years' experience working in R&D and/or new product development, process development/manufacturing engineering, or quality assurance/quality engineering is also required.
This role offers a unique opportunity to drive consistency across the organization in approaches to design controls, process development, and risk management. The ideal candidate will be committed to maintaining our culture, values, and commitment to ethics and compliance by recognising, demonstrating, and enforcing appropriate and compliant behaviour.