Position Overview:

The Supplier Quality Engineer (SQE) is essential in ensuring and continuously improving the quality of the business supplied materials. They monitor supplier performance and provide regular reports to management, ensuring transparency and accountability. The SQE also helps refine supplier control plans to drive ongoing improvements in quality standards. By collaborating closely with suppliers, they develop and implement strategies to enhance the quality of purchased products across the board. Success in this role requires strong analytical skills, the ability to multitask, and the capacity to manage multiple assignments effectively and on time.

Essential Job Functions and Responsibilities 

Develop supplier improvement plans. Conduct supplier audits and assessments to ensure compliance with quality standards. 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 determine when process stability and capability studies should be performed on existing suppliers. Analyzes and performs failure analysis on non-conforming products. Review and participate in the component qualifications (PPAP), MSA, and supplier control plans Improve and follow up on the supplier’s scorecards. Manage qualifications of changes, oversee the qualification process for changes initiated by suppliers and the company, and coordinate 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. Good communication and interpersonal skills, such as supplier relationships, internal collaboration, stakeholder management, problem solving, influencing, negotiation, and customer satisfaction.

 

Required Qualifications

Bachelor’s degree in Quality, Mechanical, or Industrial Engineering or related field. 3+ years of supplier quality. Effective analytical, technical, and problem-solving skills. Applies rigorous methodology to complex problems, including Six Sigma methodology. Experience in a medical device or other regulated industry is required.  Strong verbal and written communication skills in English are required. Knowledge of medical device regulations and standards such as 21 CFR 820, GMP, ISO 13485, and ISO 14971. Able to read and understand technical data (drawings, GD&T, etc.). Competent in using Microsoft Office suites. Sound knowledge of sampling plans and other statistical techniques. Internal or Lead Auditor certification.

Desired Qualifications  

Lean Certification a plus. Willing to work with people in an international environment. Prepared to present in front of the upper management team and the supplier.