Our client a medical device multinational currently seeks a Supplier Quality Manager to join their team. Supplier quality Manager is directly accountable for managing Supplier Quality engineering functions across multiple sites in North America & EMEA. The role will include staffing, developing, and managing a Supplier Quality Engineering team to effectively support and execute supplier qualifications, supplier maintenance, quality agreements, supplier auditing, SCARs, and supplier-driven changes. Additionally, this role will drive initiatives for optimization of Quality System deliverables and processes, and foster a positive culture of growth, collaboration, and achievement across the organization.
Role/Responsibilities
• Manage, mentor, and develop Supplier Quality Engineering teams at each of the facilities but also as in a Regional context.
• Manage teams in support of development and production, including the selection, qualification, and maintenance of suppliers.
• Demonstrate expertise and drive compliance with company policies/procedures, ISO 9001, ISO 13485, FDA QSRs, EU MDR, and other applicable standards.
• Establish strategic direction for the Regional Supplier Quality group, aligned with Global Supplier Quality strategies and including objective and goal setting.
• Assess Supplier Quality Engineering metric performance, and report to leadership teams.
• Identify, define, drive, and support strategic initiatives for Supplier Quality Engineering.
• Drive continuous improvement in Supplier Quality Engineering systems with a focus on best-in-class processes and procedures that enhance compliance and produce business efficiencies.
• Develop and maintain strong relationships and effective lines of communication with internal and external customers, as well as suppliers.
• Support internal, external, and customer inspections and Quality System audits, including preparation and direct interaction with auditors.
• Partner with New Product Development, Operations, Supply Chain, Microbiology, and Quality Assurance on organizational, procedural, and strategic initiatives and implementation.
• Provide guidance to teams through technical, system, and execution challenges.
• Partner cross-functionally to scope, staff, support, and prioritize improvement projects.
• Engage with Quality Assurance to execute and manage supplier-related non-conforming events.
Skills/Experience:
• BA/BS in Engineering or physical sciences required, master’s degree preferred.
• Minimum Five years of related experience required.
• Three years of experience managing/supervising a team.
• Minimum three years’ experience with US and international medical device regulations, standards and guidance documents.
• Ability to coach, direct and develop a high performing team of engineers and technicians. • Ability to structure and direct teams in alignment with cross functional teams.
• Establish work direction and supervision of Supplier Quality Engineering staff across all relevant sites.
• Experience with quality-related tools including, but not limited to, SPC, DOE, and TMV; experience with various process-improvement methodologies, such as Six Sigma and Lean Manufacturing.
• Communicate team and project status to senior management.
• Ability to define, organize, and manage individual and team tasks with appropriate prioritization.
• Effective verbal and written communication.
• Proficient in reviewing, assessing, and advising on technical topics.
• Interpersonal skills; working cross-functionally, in a team, and as an individual contributor. • Thorough understanding of design/process/supplier controls, risk management, statistics, and production.
• Project Management skills and experience.
For further information please contact James Cassidy james.cassidy@lifescience.ie or call in confidence 0860204322
