Job Title: Design Quality Assurance Specialist
We are seeking a skilled professional to oversee the quality and safety of our products. As a key member of our team, you will have the opportunity to work in a dynamic environment where your ideas and contributions will be valued and respected.
The successful candidate will be responsible for ensuring product quality, safety, and effectiveness by:
* Developing detailed plans for pilot production and scale-up processes in New Product Introduction programs
* Evaluating project teams to ensure they are utilizing Medical Quality Systems and adhering to industry standards throughout the product development process
* Conducting risk assessments to determine the ability of the design to function as intended
* Managing 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)
You will also be responsible for interacting with customer and supplier companies in a professional manner, proactively communicating with them to ensure an ongoing two-way exchange of information.
In addition, you will be responsible for auditing and qualifying new suppliers, intervening in and contributing to the successful resolution of technical issues when they arise, and ensuring that all work meets the requirements of our Quality Management System.
Requirements
To be considered for this role, you must have:
* A minimum Bachelor's degree in Engineering or a related field
* At least 3 years of experience in medical device design and development/quality assurance
* Excellent communication and interpersonal skills
* Demonstrated ability to lead product verification & validation activities
* Experience working with operations to develop strong manufacturing process instructions
* Familiarity with FDA QSRs, medical device regulations, and ISO 13485