Principal Supplier Quality Engineer

Qualifications

• Strong organizational, time management and project management skills with attention to detail
• Must have effective communication skills
• Able to work autonomously and independently
• Must be a team player and have a strong work ethic
• Demonstrated ability to lead, acknowledge, develop, communicate & implement strategies for developing new supplier, including qualification
• 7+ years of experience with Bachelor's degree or 10+ years of experience
• Direct experience with supplier producing product and parts in a regulatory environment (i.e
• Competent in Process Audit, CAPA, PPAP, Equipment Validation and Gage R&R

Responsibilities

• Responsible for establishing the system for managing suppliers which includes establishing systems for the approval, monitoring and validation of the suppliers
• This role is the technical liaison between our suppliers and R&D, Sustaining Engineering, and Operations
• This position focuses on strategic thinking and influencing others within the organization
• Shapes the technical direction of complex quality projects, influencing key stakeholders and driving alignment on quality strategies
• Tackles complex quality challenges, providing innovative solutions that minimize risk and ensure patient safety and product efficacy
• Leads projects with limited scope for Supplier Quality on NPD projects
• Takes a leading role in key meetings, clearly articulating project goals, technical challenges, and progress using their influence to reorient project directions and technical decisions within the team and in broader organizational contexts
• Lead PPAP process with suppliers to establish robust validated processes including measurement methodologies (Gage R&R)
• Balances risks, considers long-term impact(s)