- Ensures that biocompatibility validations are conducted in line with all quality system and regulatory requirements.
- Demonstrate a primary commitment to patient safety and product quality.
- Validates new and existing products to ensure compliance with all current biocompatibility regulatory standards.
- Coordinates a wide variety of biological or chemical tests which are performed in accordance with approved protocols and summarizes the results in a final report or qualification.
- Understands and complies with all the regulations governing the quality systems
- Supporting and providing technical scientific guidance in the development of product design, specifications and associated test methods.
- Participates in product development and sustaining teams to ensure validation of products to agreed timelines.
- Assists in documentation of validations for regulatory submissions.
- Other duties as assigned, such as: approval of test reports.
- Decision-making ability coupled with the ability to work on one’s own initiative, and with the minimum of supervision is required.
- Good interpersonal and communication (written and verbal) skills are required.
- Good administrative/organizational ability is required.
- To build quality into all aspects of work by maintaining compliance to all quality requirements
- HETAC level 8 degree (240 credits) in Science related discipline, Bioscience, Toxicology or Chemistry
- Strong Leadership & influencing skills
- Communication skills
For a confidential discussion and more information on the role, please contact Christopher O Toole