Quality Engineer

Convergent Dental Inc•Waltham, MA

10d•Onsite

About The Position

We’re seeking a proactive and detail-oriented Quality Engineer to ensure that our product development processes meet quality, regulatory and company standards. You will play a pivotal role in embedding quality into the design and development lifecycle, supporting cross-functional teams, and helping to shape our robust Quality Management System (QMS) to meet our business requirements.

Requirements

Strong knowledge of FDA QMSR, ISO 13485, ISO 14971, and EU MDR requirements.
Demonstrated problemsolving skills and the ability to analyze complex situations and make sound decisions.
Demonstrated ability to interpret engineering drawings, specifications, and technical documents.
Strong verbal and written communication skills, ability to present issues, plans, and objectives
Strong documentation, analytical, and organizational skills
Skilled in risk management techniques, root cause analysis, and statistical tools.
Excellent communication and organizational skills with the ability to work independently and cross-functionally.
Bachelor’s degree in Engineering, Biomedical Engineering, or related technical discipline.
Minimum 5 years of experience in Quality Engineering within the medical device industry.

Nice To Haves

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.

Responsibilities

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.