Job Description

As a Supplier Quality Sr. Manager, you will lead the supplier quality function, also ensure compliance, drive supplier continuous improvements and reduce risk in our supply chain. You will also lead in solving supplier quality issues and lead quality audits as part of the Global Supplier Quality team. You will manage a team of Supplier Quality Engineers located globally as well as manage Supplier Quality procedures and processes in compliance with ISO 9001/13485, FDA, GMP and other external requirements.

Key Responsibilities:
Manage Team

• Lead and develop a global team of Supplier Quality Engineers

Evaluate Suppliers

• Lead supplier evaluations to applicable standard or requirements
• Manage the approved suppliers list for local and assigned sites
• Manage the execution of objectives for the control of suppliers

Manage Supplier Quality Issues

• Collaborate with global and local departments to define actions and priorities for supplier related quality issues
• Be a champion of problem solving and root cause analysis activities with suppliers and customers to eliminate recurrence of non‐conformances
• Ensure the Supplier Quality function operates according to procedures and provides direction to other departments
• Actively participate in strategic supplier development based on risks identified through Supply Chain Risk Mitigation team

Maintain Documentation and Reports

• Review and approve supplier records including contracts, change requests, SCARs/CAPAs, NCRs, verification and validation protocols and reports
• Develop and update Supplier Quality procedures & processes in compliance with ISO 13485/9001 and GMP requirements
• Manage Supplier Quality objectives, audit requirements and tiering of suppliers

Communicate Between Suppliers and Senior Management

• Act as the liaison for suppliers on behalf of quality and purchasing, for supplier issues and work with the suppliers to develop quality and process improvements while collaborating with internal subject matter experts
• Develop supplier relationships to generate and implement quality improvements
• Monitor and report on supplier quality performance metrics of suppliers

Other Requirements

• Drive continuous improvement with procedures, policies and quality assurance methodologies including current materials, new material qualification and supplier requests for material changes
• Support Material Review Board meetings, Supplier Review Board meetings and other critical decision-making meetings as required to define Suppliers' responsibilities and effectiveness

Working Contacts:

• High level of contact with all local and global departments
• Frequent interaction with suppliers
• Liaise extensively with all other departments on matters relating to supplier quality issues. This involves working with people at all levels within the organization as well as external customers and regulatory bodies

Working Conditions / Travel Requirements:

• Office based with possibility of working remotely from home
• Visits to factories wearing PPE, including cleanroom PPE
• Frequent travel required (domestic/international)

Required Knowledge, Skills, and Abilities

A primary leader of people and processes to evaluate/audit suppliers, analyze and improve supplier performance, implement corrective actions at supplier sites to prevent repeat non-conformances. Act as the liaison for suppliers, suggest quality and process improvements while collaborating with internal subject matter experts. Manage Supplier Quality procedures and processes in compliance with ISO, FDA, GMP and other external requirements. B.S. Engineering/Operations Management, Biological Sciences or equivalent required. Quality lead auditor training certificate preferred. At least 5 years of experience in leading Supplier Quality audits required. At least 5 years of experience of Supplier Management required. At least 3 years of experience of People Management required. Solid experience with ISO 13485 required and 21 CFR Part 820 preferred. Excellent oral and written communication skills in English language required. International travel / foreign business exposure is preferred. Experience working with Supply Chain Risk Management processes and tools preferred. Advanced knowledge of quality control regulatory standards preferred. Strong knowledge of six sigma tools such as 8D, FMEA, DMAIC, Value Stream Map and Pareto Analysis preferred. Knowledge of statistical tools such as SPC, statistical sampling, DOE preferred. Strong presentations skills preferred.