Solution Driven Design Assurance Professional
We are seeking a skilled professional to join our Design Assurance team in a medical device company.
* Perform design assurance activities including technical reviews of design documentation and labelling, attend design reviews, and coordinate completion and update of design risk management documentation.
* Support projects as needed, provide quality approval on records, tests, validations, reports, and project file entries.
* Promote awareness of regulatory and customer requirements throughout the organization, perform gap analyses for projects, and implement updates to quality system requirements.
* Lead data analysis best practices, sample planning, reporting, and statistical analysis, train new hires and engineers, and support new test development and validation.
This role is ideal for those with strong problem-solving skills, attention to detail, and excellent communication skills. Experience with risk management, design controls, and validations is advantageous.
Key Responsibilities:
* Technical Reviews: Perform technical reviews of design documentation and labelling.
* Design Reviews: Attend design reviews and coordinate completion and update of design risk management documentation.
* Quality Approval: Provide quality approval on records, tests, validations, reports, and project file entries.
* Data Analysis: Lead data analysis best practices, sample planning, reporting, and statistical analysis.
Requirements:
* Risk Management: Experience with risk management, design controls, and validations.
* Problem-Solving Skills: Strong problem-solving skills, attention to detail, and excellent communication skills.
Benefits:
This role offers a challenging and rewarding opportunity to work in a dynamic team environment.