Sr. Supplier Quality Engineer - Quality Tech Services, LLC

Overview

About QTS

QTS offers critical end-of-line services for medical device OEMs including finished device assembly, packaging and sterilization management. QTS is part of the Cretex Medical family of companies. Learn more at www.qtspackaging.com and www.cretexmedical.com.
Responsibilities

Sr. Supplier Quality Engineer Ideal Candidate Profile

QTS is currently seeking an experienced, energetic, responsive and well-organized full-time Sr. Supplier Quality Engineer will be responsible for overseeing and ensuring the quality of materials and services provided by suppliers to support sustaining and new product manufacturing. This will be completed through proactive supplier management, including supplier evaluations, audits, and performance monitoring ensuring compliance with company and customer standards, material requirements, and applicable regulations, which includes identifying and resolving quality issues, managing supplier change requests, and driving continuous improvement initiatives through supplier coaching and collaboration. This position will be responsible for the definition, implementation, and improvement of supplier-related practices and procedures. The position will provide technical guidance for measurement methodologies, material qualification, validation, and problem solving.

Sr. Supplier Quality Engineer Job Summary

• Quality Engineering lead for materials and services provided by suppliers from new product introduction through sustaining.
• Lead and manage supplier corrective action and supplier change notification processes.
• Ensure compliance of supplier controls processes and agreements to applicable requirements of customers, ISO13485, FDA, and other regulations and standards as applicable.
• Provide leadership and supplier interface support for supplier quality issues through supplier quality system audits, supplier corrective action requests, supplier change requests, and technical discussions.
• Lead quality investigations using failure analysis, corrective and preventative actions, and trend analysis for customer complaints and manufacturing issues for materials and services provided by suppliers.
• Support identification of new suppliers and onboarding of suppliers through evaluation of capabilities and onboarding audits.
• Define supplier performance metrics, and proactively assess and report on supplier performance and capabilities through audits, meetings/business reviews, and performance monitoring.
• Manage the supplier audit process, including acting as lead auditor for supplier and internal audits to assess compliance with regulatory standards and company requirements, including developing an audit plan, executing audit, evaluation, follow-up, and resolution of audit observations and findings, and completing required documentation.
• Continually improve supplier performance through coaching, training, consequence enforcement, supplier motivation, and supplier roadmaps.
• Support inspection requirements and material qualification to ensure compliance with relevant requirements; facilitate PFMEAs; resolve discrepant material issues and create and maintain quality documents such as control and inspection plans.
• Understand and support validation of processes, equipment, and metrology, including creating protocols, analyzing data, and executing reports.

Qualifications

Sr. Supplier Quality Engineer Skills and Experience

• Bachelor's Degree: Mechanical, Industrial, or other Engineering or Physical science
• 7 years of experience with demonstrated ability in engineering, quality engineering, or quality control in a manufacturing setting.
• Knowledge of quality systems, regulatory requirements, and industry standards
• Process validation and material qualification.
• Regulated industry experience (ISO13485 preferred)
• Excellent problem solving and root cause analysis skills.
• Ability to read and interpret documents such as technical drawings, specifications, requirements, standards, and procedure manuals, including Blueprint reading and GD&T.
• Ability to make decisions using sound judgment while complying with policies, procedures, and applicable standards and regulations.
• Strong, clear, and effective communication and interpersonal skills.
• Statistical expertise with DOE, Capability Studies, and advanced statistical analysis methods, including statistical software (ex. Minitab)
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
• Attention to detail and organizational skills.
• Ability to work in a fast-paced team environment, multitask, and prioritize.
• Ability