Quality Assurance Engineer for Suppliers

2 weeks ago

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

Convergent Dental is at the forefront of dental innovation with Solea, a cutting-edge dental laser that performs tissue cutting without the need for anesthesia. As we continue to lead the industry, we are seeking a dedicated professional to join our dynamic team.

Position Summary:
The Supplier Quality Engineer plays a pivotal role in overseeing supplier management, production processes, and the ongoing support of the Solea product line. 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 enthusiastic individual who can work autonomously in a fast-paced environment that values initiative and ambition.

Key Responsibilities:Supplier Management:
  • 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 new components.
  • Conduct regular supplier quality audits (ISO 9001/13485) to ensure compliance among vendors and their supply chains.
  • Develop qualification test protocols and First Article Inspections (FAI), oversee testing procedures, compile test reports, and authorize components for production use.
  • Initiate and manage Supplier Corrective Actions, ensuring thorough Root Cause Analysis and effective implementation of corrective measures.
Manufacturing and Sustaining Support:
  • Offer quality and compliance insights for project decisions and deliverables, including Design Changes, Test Methods, Design Verification & Validation, Usability Testing, Process Changes, and Process Validation.
  • Assist in the implementation of robust quality assurance practices, process controls, statistical analyses, and metrics to ensure products meet or exceed both internal quality standards and regulatory requirements.
  • Provide critical quality trend data for Management Review and Complaint Reviews.
  • Support and conduct product investigations, including complaints, Corrective and Preventive Actions (CAPA), and management of nonconforming materials.
  • Utilize systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues effectively.
Qualifications:
  • Bachelor's degree in Mechanical, Biomedical, Electrical Engineering, or a related field.
  • A minimum of 3 years of experience in the medical device industry is required.
  • An advanced degree is advantageous.
  • Certification as a Certified Quality Engineer (CQE) is a plus.
Essential Skills:
  • In-depth knowledge of US and International regulations, including 21 CFR 820, Medical Device Directive, EUMDR, EN ISO 13485, and EN ISO 14971.
  • Experience in manufacturing environments and collaboration with contract suppliers.
  • Proficiency in conducting supplier audits and managing Supplier Corrective Actions.
  • Familiarity with process validation, design controls, risk management, and CAPA.
  • Proficient in Microsoft Office Suite and statistical analysis software such as Minitab.
  • Strong project management capabilities.
  • Excellent research, analytical, and communication skills, including technical writing and editing.
  • Willingness to travel domestically up to 20%.

All applicants must be authorized to work for any employer in the U.S. Convergent Dental is committed to fostering a diverse and talented workforce, and we encourage all qualified candidates to apply.

  • Quality Assurance Engineer for Suppliers

    2 weeks ago

    Waltham, Massachusetts, United States Convergent Dental Inc Full time

    Job OverviewConvergent 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...

  • Quality Assurance Engineer for Suppliers

    2 weeks ago

    Waltham, Massachusetts, United States Convergent Dental Inc Full time

    Job OverviewConvergent 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...

  • Quality Assurance Engineer for Robotics

    2 weeks ago

    Waltham, Massachusetts, United States Boston Dynamics Full time

    Position Overview:As a Quality Assurance Engineer at Boston Dynamics, you will be a key member of our Operations division, dedicated to ensuring that our robotic products are manufactured to the highest quality standards. Key Responsibilities:Your role will involve collaborating closely with Supply Quality Engineers, Product Engineers, and the Operations...

  • Staff Software Quality Assurance Engineer

    2 days ago

    Waltham, Massachusetts, United States ServiceNow Full time

    About the RoleWe are seeking a highly skilled Staff Software Quality Assurance Engineer to join our AI Search team at ServiceNow. As a key member of our team, you will be responsible for ensuring the quality and reliability of our Enterprise Search solutions.Key ResponsibilitiesDevelop and execute test strategies to validate instance automation processes and...

  • Senior Quality Assurance Leader

    1 week ago

    Waltham, Massachusetts, United States TScan Therapeutics Full time

    Position Overview:TScan Therapeutics is a pioneering clinical-stage biotechnology firm dedicated to transforming therapeutic options for patients through the identification of innovative T cells and epitopes. We are in search of a Senior Director of Quality Assurance to spearhead our Quality Assurance initiatives for both in-house and outsourced GMP...

  • Quality Assurance Specialist

    2 weeks ago

    Waltham, Massachusetts, United States Convergent Dental Inc Full time

    Job OverviewPosition Summary:The Quality Technician is responsible for supporting the inspection processes, calibration initiatives, and analysis of returned products. We seek a proactive, detail-oriented individual who can work autonomously while also collaborating effectively within a team. This role will report directly to the Director of Quality...

  • Quality Assurance Specialist

    1 week ago

    Waltham, Massachusetts, United States Convergent Dental Inc Full time

    Job OverviewPosition Summary:The Quality Technician is responsible for supporting the inspection processes, calibration programs, and analysis of returned products. We seek a proactive and detail-oriented individual who can operate independently while contributing to the team. This role reports directly to the Director of Quality Assurance and Regulatory...

  • Quality Assurance Specialist

    2 weeks ago

    Waltham, Massachusetts, United States Convergent Dental Inc Full time

    Job OverviewPosition Summary:The Quality Technician plays a crucial role in supporting the inspection processes, calibration programs, and analysis of returned products. We seek a proactive, detail-oriented individual who can work autonomously while also contributing to team objectives. This role will report directly to the Director of Quality Assurance and...

  • Design Assurance Engineer III

    3 weeks ago

    Waltham, Massachusetts, United States Boston Scientific Full time

    Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest...

  • Senior Software Quality Assurance Engineer

    2 weeks ago

    Waltham, Massachusetts, United States ServiceNow Full time

    Job OverviewCompany Overview:At ServiceNow, we empower organizations to operate efficiently and effectively. Our innovative technology transforms the way businesses function, and our dedicated team is the driving force behind this transformation. We are committed to fostering an environment where creativity and collaboration thrive, enabling our employees to...

  • Senior Quality Assurance Specialist

    2 days ago

    Waltham, Massachusetts, United States Dassault Systemes Full time

    About the RoleWe are seeking a highly skilled Senior Quality Engineering Specialist to join our team at Dassault Systemes. As a key member of our Quality Assurance team, you will play a critical role in ensuring the delivery of high-quality applications and products.Key ResponsibilitiesDesign and ValidationDevelop and execute detailed test plans to assess...

  • Quality Assurance Specialist

    2 weeks ago

    Waltham, Massachusetts, United States Aveanna Healthcare LLC Full time

    Discover Your Purpose with Aveanna Healthcare. Aveanna embodies a unique blend of compassion and dedication, creating an environment where care is delivered with a personal touch, right in the comfort of home. Experience the difference that awaits you at Aveanna. We are a healthcare organization committed to excellence in care and dedicated to the families...

  • Quality Assurance Specialist

    5 days ago

    Waltham, Massachusetts, United States Aveanna Healthcare LLC Full time

    About the RoleAveanna Healthcare LLC is seeking a highly skilled Quality Improvement Registered Nurse to join our team. As a Quality Improvement Registered Nurse, you will play a critical role in ensuring that our patients receive the highest level of care possible.Key ResponsibilitiesMaintain Compliance: Ensure that all quality assurance and improvement...

  • Clinical Quality Assurance Manager

    23 hours ago

    Waltham, Massachusetts, United States BostonGene Full time

    Job SummaryBostonGene is seeking a Clinical Quality Manager to join our Quality Assurance team. In this role, the candidate will be responsible for coordinating and facilitating Quality Assurance standards based on CAP/CLIA and Good Clinical Lab Practice (GCLP) regulatory requirements.The candidate will also be instrumental in quality assurance oversight and...

  • Clinical Quality Assurance Manager

    1 week ago

    Waltham, Massachusetts, United States BostonGene Full time

    Job SummaryBostonGene is seeking a highly skilled Clinical Quality Manager to join our Quality Assurance team. In this role, the candidate will be responsible for coordinating and facilitating Quality Assurance standards based on CAP/CLIA and Good Clinical Lab Practice (GCLP) regulatory requirements.Key ResponsibilitiesRegulatory Compliance Expertise: Serve...

  • Director of Quality Assurance and Pharmacovigilance

    1 week ago

    Waltham, Massachusetts, United States Alkermes, Inc. Full time

    Director of Quality Assurance and PharmacovigilanceThe Director of Quality Assurance and Pharmacovigilance is a key leadership position at Alkermes, Inc. responsible for overseeing the Clinical Quality Assurance Department and ensuring the quality of Post-Marketing Good Pharmacovigilance Practices (GPvP) and Commercial Operations.Key Responsibilities:Develop...

  • Director of Quality Assurance and Pharmacovigilance

    2 days ago

    Waltham, Massachusetts, United States Alkermes, Inc. Full time

    Job Summary:The Director of Quality Assurance and Pharmacovigilance is a key leadership position responsible for overseeing the Clinical Quality Assurance Department at Alkermes, Inc. This role plays a critical part in ensuring the quality and integrity of post-marketing pharmacovigilance practices and commercial operations that contribute to the company's...

  • Quality Professional II, Quality Audits

    4 weeks ago

    Waltham, Massachusetts, United States Elevatebio Full time

    ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.The Role:The...

  • Quality Assurance Specialist

    3 days ago

    Waltham, Massachusetts, United States ElevateBio Full time

    About the RoleElevateBio is a cutting-edge technology-driven company accelerating access to innovative genetic medicines. We're seeking a highly skilled Quality Assurance Specialist to support our gene and cell therapy programs.Key ResponsibilitiesExecute testing and analysis of cell and molecular biology assays in our QC laboratories.Perform peer-review of...

  • Associate I, Quality Assurance

    4 weeks ago

    Waltham, Massachusetts, United States Elevatebio Full time

    ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.The Role:ElevateBio...