The Staff Supplier Quality Engineer will directly support the design and development teams in qualifying critical materials and suppliers in support of launching innovative & life-saving medical devices. This individual will facilitate compliance to applicable internal and external requirements. You will work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success. This role will work in close partnership with R&D, Marketing, Operations, Sourcing, and RA.
- Lead part and supplier qualification activities in compliance with Edwards’s QMS requirements
- Support component specification development, identification of critical features, development of inspection methods and plans, test method validation, and component capability assessments
- Support risk management activities, including the development and implementation of FMEAs, process control plans, and quality agreements at suppliers
- Support suppliers in the development, approval and execution of process validation protocols and reports for critical processes
- Perform audits of Quality Systems and Processes at suppliers of materials, components, sub-assemblies, and services.
- Analyze and support the effective resolution of complex manufacturing and compliance issues at suppliers resulting from audit observations, incoming/process non-conformance reports, and customer complaints
- Utilize statistical techniques and six sigma tools to analyze processes and drive continuous improvement activities
- Collect and analyze Quality metrics relating to Supplier Quality
- Guide quality engineers as a subject matter expert in technical areas
- Communicate supplier quality risks to management or internal teams during reviews and project meetings, and identify solutions to mitigate risks.
- Support process and system improvement projects as assigned by manager
- Bachelor degree in technical or science field with a minimum 5 years’ experience or master’s degree plus 4 years’ experience in medical device manufacturing.
- Knowledge and understanding of FDA and international regulatory standards for medical devices is required.
- This role involves management of multiple and frequently changing projects and priorities. Highly developed time management, communication, and documentation skills are required.
- Excellent documentation and communication skills and interpersonal/intercultural relationship skills including influencing, negotiating and relationship management skills.
- Ability to work independently without close supervision.
- Advanced understanding of V&V, statistical techniques, test method development, and risk management.
- Demonstrated ability to apply statistical quality engineering tools in a supplier environment is required.
- Ability to read and interpret drawings.
- Serves as best practice/quality resource within own discipline or as technical expert on functional or cross-functional teams or projects.
- ASQ Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), Certified Quality Engineer (CQE), or related quality certifications preferred.
- General understanding of plastic manufacturing or metal fabrication methods are a plus.
- Experience with Class III medical devices required, and experience with implantable devices preferred
Domestic and international travel is required. Expected 25% travel.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.