Main Responsibilities/Main Tasks
- Forming a sustainable quality culture based on compliance to regulations, patient safety, and continuous improvement of quality processes to benefit the end customer.
- Partnering with the business leadership team to drive wing-to-wing product quality through critical metrics trend analysis and implementation of improvement initiatives for the total product life cycle.
- Managing the Quality Management Reviews in EMEA.
- Acting as the interface between EMEA and the global QA/RA function, implementing central programs in an appropriate compliant manner.
- Driving training, enhancement, and adoption of the QMS framework and tools.
- Providing effective guidance and oversight for quality assurance and regulatory processes, as well as owning key decisions for the total product life cycle.
- Ensuring compliance to existing and applicable global Quality Systems Requirements.
- Translating new industry trends and requirements into business policies and practices.
- Managing internal and external audits across the EMEA and DE business to ensure compliance as required by the business and regulatory agencies.
- Staffing and managing a globally disperse team of QA/RA professionals with the required skills and experience to execute their job responsibilities.
- Direct Reports: EMEA QA and RA functions
- Dotted Line Reports: Part time country QA/RA employees