Job Opportunity
We are seeking a Design Assurance Program Manager to lead our quality assurance initiatives.
Responsibilities:
* Oversee the development and implementation of quality systems and processes, ensuring compliance with regulatory requirements and industry standards.
* Collaborate with cross-functional teams to establish design history files and device master records, and conduct risk assessments to ensure product safety and efficacy.
* Investigate and evaluate material biocompatibility and sterilization methods to ensure product integrity.
* Develop and implement corrective and preventive actions (CAPA), change control, and notification procedures, and conduct internal and vendor audits.
* Communicate effectively with customers and suppliers to ensure successful project outcomes.
* Solve technical issues proactively and ensure that all work meets quality standards.
* Ensure ongoing improvement and compliance opportunities.
Required Skills and Qualifications:
* Bachelor's degree in Engineering or related field.
* 6+ years of medical device design and development/quality assurance experience required.
* Proven ability to lead product verification and validation activities.
* Experience working with operations to develop strong manufacturing process instructions and operator training desired.
About This Role
This is an exciting opportunity for a quality assurance professional to join our team and contribute to the development of innovative medical devices.