Director Of Quality

There is a fantastic opportunity for a Director of Quality position available for a growing firm located in Lexington, MA. The Director of Quality will be reporting to the VP of Clinical, Regulatory Affairs, and QA with extensive experience working with IVD. This position offers the opportunity to work in an innovative firm that specializes in developing products that detect immunoassay targets.

The Director of Quality will be an essential role in supporting product quality and quality system compliance while also managing multiple programs. Establishing the Quality System to be compliant with IVDD, EN, ISO, and QSR regulations and preventing defects in products will be a key component of this role. This opportunity offers you the ability to manage a growing team and to work in an innovative environment.

Key Responsibilities Include:

- Participating in Third Part Audits and approving test development, protocols, reports, inspection instructions, and design reviews.
- Responsible for coordinating Quality System Training and for New Hire Training
- Supporting the regulatory submission process in compliance with IVDD, ISO, and FDA Regulations
- Ensuring product quality test protocols and final reports are established and approved
- Maintaining the Document Control System and auditing the product device history record
- Overseeing Supplier Quality System
- Developing the QA team and making sure projects are completed in a timely manner
- Playing a key role in developing company policies and operating procedures

Key Requirements Include:

- BS degree in a scientific or allied health field
- Great knowledge of biochemical inspection equipment
- 5 years experience working with IVD in a Quality role
- Preferred experience includes working with instruments and assays

Please reach out if you are interested in this role or would like to speak about other opportunities!To find out more about Real Staffing please visit www.realstaffing.com