Job Title: Principal Product Quality Specialist
Overview
We are seeking an experienced and skilled Principal Product Quality Specialist to join our team.
Responsibilities
* Support the sustainability of commercial projects from a Design Assurance perspective, ensuring products comply with global standards throughout their lifecycle.
* Facilitate the introduction and implementation of product, process, and material changes in manufacturing, assessing patient risk for design changes.
* Provide QA technical direction and input for qualification and validation activities in collaboration with R&D and Manufacturing Engineering.
* Develop Design Verification protocols and contribute to the compilation of design verification and shelf life data for regulatory submissions.
* Interface with Regulatory Affairs to ensure clear presentation of information, minimizing Regulatory Agency queries.
* Establish strong cross-functional relationships within the organization and with external partners in a complex technical environment.
* Maintain up-to-date knowledge of regulatory compliance requirements for product design, development, and commercialization.
* Generate and approve change requests, lead investigation analyses, and ensure timely completion.
* Collaborate with engineering and manufacturing functions to ensure quality standards are upheld.
Requirements
* Bachelor Degree (Level 8) in Engineering or similar discipline.
* 5 years experience working in a similar role ideally with design assurance experience.
* Strong knowledge of regulatory compliance requirements for product design, development, and commercialization.
* Excellent cross-functional collaboration skills.
* Ability to generate and approve change requests and lead investigation analysis.
* Proficiency in designing or specifying inspection and testing mechanisms and equipment.
* Understanding of risk management concepts and compliance with FDA, ANSI/AAMI/ISO standards.
What We Offer
* A hybrid work environment offering flexibility.
* A collaborative and innovative work culture.