Product Design Assurance Professional
This role is ideal for someone with a meticulous approach to quality, who can scrutinize product designs and ensure they meet the highest standards.
Key Responsibilities:
* Collaborate closely with cross-functional teams, including design, manufacturing, regulatory affairs, and compliance.
* Lead thorough risk assessments on new products, using FMEA tools to rigorously test designs.
* Provide expert quality support across R&D, design, validation, and testing methods.
* Review product documentation to guarantee compliance with ISO standards.
* Conduct statistical analysis and DOE to optimize products and processes.
* Support studies through different testing phases, ensuring product robustness.
* Contribute to biocompatibility assessments, protocol writing, and method validation.
* Engage in internal and supplier audits, driving continuous improvement.
Requirements:
* Degree in Engineering, Science, or Technical discipline.
* Minimum 5 years' experience in medical devices or pharmaceuticals.
* Strong knowledge of risk management and regulatory compliance.
* Experience with FMEA and other risk management tools.
* Skilled in statistics, validation, and testing methods.
* Proven ability to scrutinize and stress-test designs to ensure product reliability.
* Strong communicator, able to work collaboratively and independently.
About this role
We are seeking a skilled professional to join our team as a Product Design Assurance Professional. This role is responsible for ensuring the quality and safety of our products throughout the design process.
Benefits
In addition to a competitive salary and benefits package, this role offers opportunities for professional growth and development in a dynamic and supportive environment.