Quality Engineer

Overview

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.

• 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.

• Strong knowledge of FDA QMSR, ISO 13485, ISO 14971, and EU MDR requirements.
• Demonstrated problem-solving 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.
• 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.

Location:

Waltham, MA 02451; 4-5 days onsite required

Full-Time

Director of Quality and Regulatory