Job Overview
Develop and refine quality system policies and procedures for new product development (NPD). Ensure that policies and procedures meet the needs of stakeholders and regulatory expectations.
Key Responsibilities:
- Work across functional teams to develop and implement global policies and procedures for design controls, process development, and risk management.
- Develop an understanding of applicable standards, regulations, and guidance documents affecting design controls, process development, and risk management.
- Coordinate implementation of global policies and procedures with local sites and operations personnel. Support other companies as needed to implement global quality system policies and procedures.
Required Skills and Qualifications
* Bachelor's degree in Engineering or Science, preferably in Mechanical, Chemical, Manufacturing, or Biomedical disciplines.
* Experience developing and managing policies and procedures.
* At least 5 years' experience working in R&D, process development/manufacturing engineering, systems engineering - design controls, process development, and/or risk management, quality assurance/quality engineering.
* Effective oral and written communication skills.
* Excellent problem-solving skills and ability to work in collaborative and independent environments.
* Experience working in a global environment/global teams across many cultures and regions, managing and executing complex projects/programs in an engineering environment.
Benefits and Opportunities
This role offers the opportunity to work on a global scale, collaborating with cross-functional teams to drive business success. If you are a motivated individual with a passion for quality and innovation, this could be the perfect opportunity for you.