Sr. Quality Engineer

Senior Quality Engineer
Location: Newton, MA
Employment Type: Full-Time

Company Overview

A dynamic, fast-paced medical device company specializing in wound care and hemostasis is seeking a Senior Quality Engineer. This commercial-stage organization offers a portfolio of FDA-cleared and patent-protected technologies used across healthcare settings including surgery, emergency medicine, wound care, and public safety.

Position Summary

The Senior Quality Engineer will play a pivotal role in supporting the company's next phase of growth. This individual will work closely with contract manufacturers and internal teams to ensure product quality, regulatory compliance, and continuous improvement.

Key Responsibilities

• Evaluate and improve contract manufacturers' processes through research, design, and collaboration.
• Develop and optimize manufacturing processes and equipment in partnership with vendors.
• Onboard and manage contract manufacturers, ensuring regulatory compliance.
• Enhance manufacturing efficiency through workflow and layout analysis.
• Design and implement testing methods to ensure product and process quality.
• Serve as a key resource for manufacturing and quality-related inquiries.
• Ensure compliance with regulatory standards to maintain product reputation.
• Support design and development projects, including training contract manufacturers.
• Maintain quality engineering functions such as supplier controls, audits, and validations.
• Participate in Material Review Board and CAPA processes to address non-conformances.
• Provide design control support for new product development, including risk management.
• Drive continuous improvement of the Quality Management System (QMS).
• Conduct internal and supplier quality audits.
• Create and maintain documentation for product specifications, validations, and design history files.
• Support QMS functions such as document control, training, and device history record management.

Qualifications

• Bachelor's degree in engineering or a related technical field, or equivalent experience.
• 6-8 years of experience in manufacturing and supplier quality engineering.
• Experience with process validations and contract manufacturer management.
• Background in medical devices and FDA-regulated industries.
• Strong knowledge of ISO 13485 standards.
• Excellent communication, organizational, and project management skills.
• Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Strong analytical and problem-solving abilities with a proactive mindset.