Partner with SQP and applicable stakeholders to ensure completeness and appropriateness of applicable milestone deliverables to ensure milestone readiness and achievement
Review and approve milestone deliverables within development projects
Represent Pre Market Quality in mQMS Communities of Practice (e.g. for IRM/ Change Control/ D&D module)
Support internal and external audits
Drive standardization of deliverables across all projects and Customer areas (i.e. templates, review process, content, other)
Ensure timely execution and quality process management for design change requests, NCs and CAPA
Models behavior to support and enable new ways of working and a culture of continuous improvement
Adopt Risk Enabler in decision decision making
Reduce complexity and drive continuous improvement across customer areas with pragmatic solutions
Additional tasks:
Embed and continuously improve knowledge management within Pre Market Quality, fostering the effective sharing and retention of valuable knowledge and expertise.
Ensure effective change management in Product Development Quality, R&D and other functions
Foster a culture of innovation and continuous improvement, nurturing a creative and problem-solving mindset throughout Product Development Quality and other functions
Serve as a role model, exhibiting behaviors that support the transition to a new operating model emphasizing agility, collaboration, and adaptability.
Drive decision-making, ensuring timely and informed decisions are made, and obtaining commitment for implementation.
Serve as a coach, supporting colleagues to grow and develop their skills, fostering a learning and development-oriented environment
Reduce complexity and drive continuous improvement across customer areas with pragmatic solutions
Inspire the organization to thinks in terms of impact and outcomes rather than tasks
***Pay rate is commensurate with experience. Target pay rate range is $55-65/hr***