Responsible for the quality management of local and international suppliers. This role includes but is not limited to supplier selection, approval, management, monitoring, auditing, corrective action management and development. Work in team environment with suppliers to develop and implement best practices that emphasized defect prevention, reduction in variation and drives continuous improvements to meet all requirements. Among main responsibilities are:
- Quality performance management
- Ongoing monitoring of supplier performance to established KPI’s via supplier scorecard and monthly reporting
- Facilitate root cause analysis and supplier corrective action management
- Establishes accountability for effective implementation and compliance of Nextern supplier quality system requirements.
- Lead the supplier approval and evaluation process based on capabilities, quality system, processes, controls and alignment with company standards
- Lead supplier change request and approval process
- Perform quality system, process, and product audits and quality reviews remotely and onsite at suppliers.
- Manage the approve supplier list, preferred supplier list and approved supplier by component process.
- Work with suppliers to improve specifications, develop standards and methods for inspection and test
- Work with engineering and supply chain to setup new suppliers
Requirements
- Bachelor's degree in engineering, administration, or equivalent combination of education and experience.
- 3+ year relevant medical device supplier quality experience
- Experience with the full range of ISO 13485 and FDA GMP, as it is associated to Class II and III medical device design, manufacturing, servicing, and distribution.
- Experience writing, changing, and auditing company/site level quality managing system procedures, compliant with ISO 13485 and FDA GMP.
- Experience managing and assuring the effectiveness of global Quality System Audit (internal, customer, regulators) processes. (desirable)
- Experience with Risk management as outlined in ISO 14971 (desirable)
- Demonstrated technical expertise and leadership in quality
- Demonstrated use of Quality tools and methodologies
Benefits
Competitive compensation package.