- Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system.
- Understands and complies with all the regulations governing the quality systems
- Ensures their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
- Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality Assurance recommendations.
- Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
- Participates in Customer Complaints investigation for areas under their control
- Demonstrates and actively promotes highest levels of professional QA engineering discipline and rigor.
- Is viewed as a leader in the areas of QSR and ISO/MDD standards within ones own group, constantly promotion awareness of best industry practices making appropriate decisions on a daily basis using the Quality Engineering Manager/Site QA Director as the final arbitrator on critical quality decisions.
- Has significant expertise in validation engineering and is thoroughly familiar with all regulatory requirements.
- Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
- Champions continuous improvement and innovation from a quality perspective within the department right from vendor selection/approval through to customer awareness/satisfaction.
- Is an effective team member, fully motivated to achieve and demonstrate best practices in line with the department and LRP objectives.
- Gives technical guidance to Quality Engineers, Associate Quality Engineers, technician and inspection staff.
- Works with EHS to identify significant environmental impacts of their operations and to establish goals and targets around significant environmental impacts
- Deals with suppliers, other engineering disciplines within and outside of Site and customers should the need arise
- Is familiar with the internal auditing process.
- To build quality into all aspects of work by maintaining compliance to all quality requirements
- A Bachelor (HETAC level 8) of Engineering, Sciences or equivalent experience with a minimum of 8 years experience in a healthcare environment.
- A thorough working knowledge of Risk Management and Validation techniques.
- Experienced in the application of Six Sigma techniques.
- People management experience desirable.