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Quality Assurance Engineer for Suppliers

2 months ago

Waltham, Massachusetts, United States Convergent Dental Inc Full time
Job Overview

Convergent Dental is at the forefront of dental innovation with our flagship product, Solea, a cutting-edge dental laser that operates without anesthesia. As we continue to lead the industry, we are seeking a dedicated professional to enhance our supplier quality processes.


Position Summary:

The Supplier Quality Engineer plays a pivotal role in managing supplier relationships, overseeing manufacturing processes, and ensuring the sustainability of the Solea product. This position requires collaboration with external contract manufacturers and component suppliers, as well as internal teams such as Manufacturing, Research & Development, Regulatory Affairs, Marketing, Customer Success, IT, and Field Service. We are looking for a proactive and motivated individual who thrives in a dynamic environment and can work autonomously.


Key Responsibilities:
  • Supplier Management:
    • Maintain and update the supplier database while evaluating potential new suppliers for their technical, quality, and manufacturing capabilities.
    • Conduct regular supplier quality audits to ensure compliance with ISO 9001/13485 standards.
    • Develop qualification test protocols and monitor testing processes, ensuring all components meet production standards.
    • Initiate and oversee Supplier Corrective Actions, ensuring thorough Root Cause Analysis and effective implementation of corrective measures.
  • Manufacturing and Sustaining Activities:
    • Provide quality and compliance insights for project decisions, including design changes and usability testing.
    • Support the establishment of quality assurance processes and metrics to ensure products meet both internal and regulatory standards.
    • Deliver key quality trend data for management reviews and complaint assessments.
    • Assist in product investigations related to complaints and nonconforming materials.
    • Utilize systematic problem-solving techniques to identify and resolve quality issues effectively.

Qualifications:
  • Bachelor's degree in Mechanical, Biomedical, Electrical, or a related engineering discipline.
  • A minimum of 3 years of experience in the medical device industry.
  • An advanced degree and CQE certification are advantageous.

Essential Skills:
  • Comprehensive knowledge of US and international regulations, including 21 CFR 820 and ISO standards.
  • Experience working on the manufacturing floor and with contract suppliers.
  • Proficient in conducting supplier audits and managing corrective actions.
  • Familiarity with process validation, design controls, and risk management.
  • Proficient in Microsoft Office Suite and statistical analysis software.
  • Strong project management and analytical skills.
  • Excellent written and verbal communication abilities.
  • Willingness to travel domestically as required.

Convergent Dental is committed to fostering a diverse workforce. We encourage all qualified candidates to consider this opportunity.