Overview
The successful candidate will be involved in new product development activity withing a dynamic Quality Assurance team of a mid-size medical device company that are revolutionizing healthcare through ground-breaking technologies.
Responsibilities
Collaborate with product development teams to establish and implement quality plans for new and existing products.
Ensure product development activities adhere to FDA regulations, ISO standards, and other relevant quality and regulatory requirements.
Conduct risk assessments and support the development of risk mitigation strategies.
Identify opportunities for process improvement and collaborate with cross-functional teams to implement changes including design engineering teams.
Maintain accurate and up-to-date documentation of quality processes, procedures, and test results.
Qualifications
A BS in Engineering or a related field
A minimum of 3 years’ experience in Quality Assurance
A minimum of 3 years’ experience in the Medical Device Industry
Experience in Process and Production Validation and Statistical Methods
Excellent communication skills and attention to detail