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Quality Assurance Engineer for Suppliers
2 months ago
Convergent Dental has pioneered the development of Solea, a revolutionary dental laser designed to cut tissue in the oral cavity without the need for anesthesia. Solea has rapidly established itself as the leading hard and soft tissue laser in the dental industry. This is an exciting opportunity to be part of a forward-thinking organization that is set to transform the dental landscape for practitioners and their patients.
Position Summary:
The Supplier Quality Engineer plays a vital role in supporting supplier management, production, and the ongoing maintenance of the Solea product. This position involves collaboration with external contract manufacturers and component suppliers, as well as key internal departments such as Manufacturing, Research & Development, Regulatory Affairs, Marketing, Customer Success, IT, and Field Service. We seek a proactive, highly motivated individual who can work autonomously and thrives in a dynamic environment that values initiative and dedication.
- Maintain and update the supplier database while evaluating potential new suppliers for their technical, quality, and manufacturing capabilities. Provide technical assistance during the onboarding of components from new suppliers.
- Conduct regular supplier quality audits (ISO 9001/13485) to ensure compliance among vendors and their suppliers.
- Develop qualification test protocols and First Article Inspection (FAI), oversee testing processes, complete test reports, and authorize components for production use.
- Initiate Supplier Corrective Actions and ensure thorough Root Cause Analysis and effective implementation of corrective measures.
- Provide quality and compliance insights for project decisions and deliverables, including Design Changes, Test Methods, Design Verification & Validation, Usability Testing, Process Changes, Process Validation, and Labeling.
- Support the establishment of robust quality assurance processes, control measures, statistical analyses, and metrics to ensure products meet or exceed both internal quality standards and regulatory requirements.
- Deliver critical quality trend data for Management Reviews and Complaint Reviews.
- Assist in product investigations related to complaints, Corrective and Preventive Actions (CAPA), and nonconforming materials.
- Utilize systematic problem-solving techniques to identify, prioritize, communicate, and resolve quality issues (e.g., 5 Whys analysis, Is-Is Not analysis, and Six Sigma methodologies).
- Bachelor's degree in Mechanical, Biomedical, Electrical, or a related engineering discipline.
- A minimum of 3 years of experience in the medical device sector is required.
- An advanced degree is advantageous.
- Certification as a Certified Quality Engineer (CQE) is a plus.
- Comprehensive understanding of US and International regulations, including 21 CFR 820, Medical Device Directive, EUMDR, EN ISO 13485, and EN ISO 14971.
- Experience working on the manufacturing floor and with contract supplier manufacturing processes.
- Proficient in conducting supplier audits and managing Supplier Corrective Actions.
- Knowledgeable in process validation, design controls, risk management, and CAPA.
- Familiarity with Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent).
- Ability to manage multiple projects effectively.
- Strong research and analytical capabilities.
- Excellent written and verbal communication skills, including technical writing and editing.
- Willingness to travel domestically up to 20%.
Convergent Dental is dedicated to fostering a diverse and talented workforce. All candidates are encouraged to apply. If you are enthusiastic about this position but are uncertain whether you meet all the requirements, we invite you to inquire and/or submit your application.
