This role oversees multiple concurrent projects to ensure regulatory and quality compliance is maintained throughout the product development lifecycle into manufacturing and sustainment
Job Summary
This role oversees multiple concurrent projects to ensure regulatory and quality compliance is maintained throughout the product development lifecycle into manufacturing and sustainment.
You may ensure suppliers deliver products which comply with requirements and specifications.
Meet company and departmental goals in the continuous improvement of all products, services and processes, including the West QMS.
Matching Summary
This role oversees multiple concurrent projects to ensure regulatory and quality compliance is maintained throughout the product development lifecycle into manufacturing and sustainment.
Skills & Requirements
Must-have
Quality Management System best practices
Regulatory and quality compliance
Supplier compliance with requirements
Enhance supply chain quality processes
Develop quality engineering methodologies
Cross-functional team collaboration
Nice-to-have
Continuous improvement of products and processes
Strong problem-solving skills
Adaptable to changing work environment
High attention to detail and accuracy
Key Requirements
Bachelor's Degree in Engineering or Science or equivalent experience
Minimum 5 years of experience in a regulated industry
Demonstrated experience (4+ years) independently defining, planning, and executing projects
In-depth knowledge of cGMP regulations, ISO 17025, ISO 11040, ISO 13485, 21 CFR 820, ISO 14971
Proficiency in standard project management tools and software
Proficient in statistical software, Windows OS, Microsoft Office Suite