Senior Quality Engineer

POSITION SUMMARY

This position will be responsible for the management of suppliers within the Supplier Quality team and is accountable for the evaluation, qualification, monitoring, and approval of new and existing suppliers. This position will also help lead the oversight of supplied materials and services to ensure supplier controls are maintained per international requirements and Quality System Regulations. This role will also assist with the internal audit program.

TASKS AND RESPONSIBILITIES:

• Provide technical support for activities related to supplier quality system assessments and performance evaluations.
• Negotiate and execute Quality Agreements.
• Lead and Support Supplier Quality improvement projects and initiatives
• Review and coordinate Supplier Change Notifications
• Issue and monitor Supplier Corrective Actions.
• Coordinate and execute supplier and internal audits.
• Train, mentor, and coach team members on supplier quality principles.
• Drive and build collaborative working relationships with cross functional teams and suppliers.
• Supports internal audits and inspections.

QUALIFICATIONS & BACKGROUND

• Bachelors Degree in a scientific discipline.
• Minimum of 5 years of supplier management and auditing experience in a related industry.
• Knowledge in IVDD/IVDR, ISO 13485, and CAP/CLIA preferred.
• Effective written and oral communication skills; ability to write, type, express or exchange ideas accurately.
• Ability to organize and manage multiple projects or tasks.
• Quality orientation and high attention to detail.
• Travel Required