Global medical devices leader seeks a Supplier Quality Engineer with a focus on developing key suppliers and contract manufacturers. The Supplier Quality Engineer will work on a new, innovative Class III medical device. Anticipated travel is 25% both domestic and international. The Supplier Quality Engineer will work cross-functionally with Quality, R&D, and Operations in the development, qualification, improvement, and management of suppliers.
Our medical device clients seek quality assurance engineers who are career-driven, have strong analytical and technical skills and a depth of experience in managing quality systems. Our companies offer excellent career growth potential, and excellent benefits. We have many opportunities – all with top medical device companies seeking the best in quality assurance leadership.
typical roles and responsibilities for Supplier Quality Engineer
Lead part qualification and supplier qualification activities
Develop inspection methods and plans, test method validation, and component capability assessments supporting component specification development and the identification of critical features,
At key supplier sites, lead risk management activities, including the development and implementation of FMEAs, process control plans, and quality agreements
Support suppliers in the development, approval and execution of process validation protocols and reports for critical processes
Perform quality systems and processes audits at supplier sites which provide materials, components, sub-assemblies, and services.
Analyze and support the resolution of complex manufacturing and compliance issues at supplier sites
Utilizing statistical techniques and six sigma tools, analyze processes and drive continuous improvement activities
Collect and analyze quality metrics relating to supplier quality
Train, coach and mentor quality engineers as a subject matter expert in key technical areas
Communicate supplier quality risks to upper management identifying solutions to mitigate risks
Support process and system improvement projects as assigned by manager
Requirements for the Supplier Quality Engineer
Bachelor’s degree preferably in engineering, preferred disciplines could include mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering; advanced degree preferred
ASQ CQE preferred
5+ years in medical device manufacturing with a depth of experience the development of suppliers and contract manufacturing operations
Extensive experience in new process qualification, including IQ, OQ, PQ
Experience with Class III medical devices including working knowledge of process transfer, scale up and process design, manufacturing
Strong knowledge and understanding of FDA’s 21 CFR Part 820, ISO13485, ISO9001, and other International regulations
Demonstrated engineering experience in supplier quality, supplier development, new product development, or manufacturing engineering in medical device or other regulated industry
Thorough understanding of risk management principles and techniques
Experience with the use of statistical techniques, Six Sigma tools, and DMAIC problem-solving techniques.
Strong problem-solving and critical thinking skills.
Ability to effectively communicate across different levels of the organization
Ability to work independently without close supervision
Ability to manage competing priorities in a fast-paced environment
Strong interpersonal skills, with the ability to negotiate and influence change.