Supplier Quality Engineer II

This role involves maintaining and improving quality engineering methodologies, conducting supplier audits, and collaborating with cross-functional teams to address quality concerns. A deeper understanding of medical device manufacturing and quality systems is required.

Requirements

• Conducts activities concerned with the quality assurance of a given commodity set by working closely with suppliers, manufacturing, purchasing, and supplier quality.
• Analyzes processes and contributes to improvements.
• Collaborates with cross functional/development teams to address quality concerns, drive improvements, and take ownership of technical solutions and their outcomes.
• Assists in the review and approval of supplier corrective action plans and assists in the investigation of any supplier-related complaints.
• Identifies and communicates risks, participates in issue resolution, and mentors junior engineers.
• Assists in identifying/evaluating risks and contributes to risk mitigation.
• Participates in new product development teams and component qualification process as needed to carry out approvals for given components.
• Conducts and documents regular visits/audits to assigned suppliers to review manufacturing processes, quality systems/controls, pre-launch readiness, root cause identification, corrective actions, and process improvement opportunities.
• Applies advanced engineering methods and tools to solve engineering problems. Identifies and contributes to process improvements utilizing six sigma techniques.
• May assist six sigma training at suppliers.
• Assists in developing and maintaining supplier quality improvement programs and metrics.
• Participates in either back room or front room in support of MDSAP (or equiv.) audits.
• Assists in internal audits.