In this role, you will provide Quality and Engineering support and guidance to ensure compliance to the requirements of the medical device quality system focused on combination products for biological therapeutics developed in-house and in collaboration with partners and CMO's.
The individual will be responsible for designing, developing, and implementing security controls to preserve the confidentiality, integrity and availability of information systems; assist in successfully integrating security configuration procedures and tools on Linux and Windows platforms.
In this role, you will be utilizing your excellent verbal and written communications skills you will identify and help projects to ensure areas of responsibility are streamlined, and business / user friendly.
In this role, you will implement quality assurance programs in various areas as directed by the Quality Manager. The selected candidate will be concerning operating conditions, methods and procedures for the purposes of improvement of quality and the reduction of costs.
The Business Analyst will be responsible for working closely with the project manager, core technical team members and other project stakeholders and assisting with all aspects of the System Development Life Cycle (SDLC).
In this role, the selected candidate will be responsible for specific projects, e.g. process improvements, implementation of new instrumentation; interact with outside customers and functional peer groups.
In this role, the selected candidate will drive communication with supplier to improve producibility and manufacturing process capability of mechanical, electrical, electromechanical and electronic commodities.