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.
Salary range for Supplier Quality Engineer