Quality Engineer

Convergent Dental

Quality Engineer ensuring compliance with regulatory standards and quality management in medical device development. Leading design control and cross-functional collaboration at Convergent Dental in Waltham, MA.

Posted 4/24/2026full-timeWaltham • Massachusetts • 🇺🇸 United StatesMid-LevelSenior💰 $90,000 - $135,000 per yearWebsite

About the role

Key responsibilities & impact

Serve as the quality representative on design and development projects, from concept through commercialization.
Ensure compliance with applicable standards and regulations, including ISO 13485, FDA 21 CFR Part 820, and EU MDR.
Lead and support design control activities: risk management (ISO 14971), design inputs/outputs, verification and validation, design reviews, and design history file (DHF) maintenance.
Develop and implement quality plans, test strategies, and protocols for new product development.
Drive root cause analysis and corrective/preventive actions (CAPA) related to product design and development.
Monitor and analyze quality metrics and trends.
Support development and continuous improvement of the Quality Management System.
Review and approve Engineering Change Orders (ECOs), test protocols, and technical documentation.
Collaborate with Product Management, Engineering, R&D, Regulatory, Manufacturing, Customer Success and Clinical teams to ensure quality is integrated throughout the product lifecycle.
Support internal, external audits and regulatory inspections.
Participate in post-market surveillance activities, including complaint handling, adverse event reporting, and product recalls.
Analyze post-market data and trends to identify opportunities for product and process improvements.

Requirements

What you’ll need

Bachelor’s degree in Engineering, Biomedical Engineering, or related technical discipline.
Minimum 5 years of experience in Quality Engineering within the medical device industry.
Experience in quality assurance or regulatory affairs within a regulated industry (e.g., FDA-regulated medical device) preferred.
Experience working in a smaller, more agile environment is a strong plus.
Experience working with contract manufacturers and suppliers.
Experience with software as a medical device (SaMD) or digital health technologies preferred.

Benefits

Comp & perks

Medical Insurance (CIGNA - 4 plans to choose) w/ HRA
Dental (CIGNA) & Vision (EyeMed)
Voluntary Short-Term Disability
Long-Term Disability
Flexible Spending Accounts
401(k) Plan with Company Match
Paid Time Off

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

quality assurancerisk managementdesign controlverification and validationroot cause analysiscorrective actionspreventive actionsquality metrics analysisquality management systempost-market surveillance

Soft Skills

collaborationleadershipcommunicationproblem-solvinganalytical thinking