Job Title: Project Manager Design Assurance
The successful candidate will lead quality representative on projects, providing guidance to establish appropriate Design History File / Device Master Record documentation.
In this role, you will ensure project teams are utilizing quality systems and appropriate regulations and industry standards throughout the product development process.
You will investigate and evaluate material biocompatibility and appropriate methods of sterilization during the product design cycle.
Additionally, you will conduct risk assessments of the design to determine the ability to function as intended.
You will be responsible for timely Corrective and Preventative Actions (CAPA), change control and notification, internal and vendor audits, product release, document control, design control process, and design history files (DHF), device master records, etc.
This role requires strong leadership skills, with the ability to intervene and contribute to the successful resolution of technical issues when they arise.
Skills and Qualifications include: Minimum Bachelor's degree in Engineering or related field; 6+ years of medical device design and development/quality assurance experience; ability to manage customer relationships and responses in a timely manner; and demonstrated ability to lead product verification & validation activities.