Senior Supplier Quality Engineer

Position Overview:

The Senior Supplier Quality Engineer plays a critical role in maintaining and enhancing the quality of supplies procured by the business. They oversee supplier performance, providing regular reports to management to ensure transparency and accountability. Additionally, they contribute to the refinement of supplier control plans, aiming for continuous improvement in quality standards. By collaborating with suppliers, the SQE helps develop and implement strategies to elevate the quality of purchased products across the board.

Responsibilities:

• Develop Supplier Improvement Plan.
• Ensure Supplier Audit Schedule Compliance.
• Supplier Trend Analysis to develop strategy.
• Follow Up Corrective Actions, ensuring the implementation of corrective actions in response to quality issues, while also assessing the adequacy of root cause analysis tools employed to address reported issues.
• Support or execute change orders for process improvements and determines when process stability and capability studies should be performed on existing suppliers.
• Analyzes and performs failure analysis to non-conforming products.
• Review and participates in the Component Qualifications (PPAP), MSA and supplier Control Plans.
• Provides input to supplier’s scorecards.
• Manage qualifications of changes, overseeing the qualification process for changes initiated by suppliers and the company, and coordinating associated change control activities to ensure seamless integration and compliance with quality standards.
• Develops and prepares monthly suppliers quality trend analysis and reports.
• Team Member in Supplier Qualification and Maintenance process, including audits.

Required Qualifications

• Bachelor's degree in engineering or technical field.
• Minimum of 7+ years of supplier quality or working with supplier qualification projects experience in a medical device or other regulated industry is required.
• Strong verbal and written communication skills in English is required.
• Knowledge of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO 13485, and ISO 14971.
• Able to read and understand technical data (drawings, GD&T, etc).
• Lead Auditor certification a plus.
• Lean Certification a plus.
• Competent using Microsoft Office suites.
• Experience with statistical analysis software.
• Effective analytical, technical, and problem-solving skills. Applies rigorous methodology to complex problems, including six sigma methodology.
• Ability to multi-task and manage multiple assignments in a timely manner.
• Good communication and interpersonal skills, such as supplier relationships, internal collaboration, stakeholder management, problem solving, influencing, negotiation and customer satisfaction.
• Strong analytical skills.