Staff Quality Engineer – Boston, MA - $160k - $170k

This global leader in medical technology is dedicated to improving patients’ lives through cutting-edge solutions in regenerative medicine and surgical care. With a strong focus on innovation, collaboration, and quality, the company empowers healthcare professionals worldwide

The Staff Quality Engineer is a subject matter expert in product quality and compliance, supporting product design, manufacturing, and quality systems in a regulated environment. This role involves driving quality initiatives, managing risk (pFMEA), process validation, and CAPA resolution. The engineer collaborates across teams to ensure compliance with FDA, ISO, and other regulatory standards, focusing on improving processes and equipment while mentoring junior team members.

Key Responsibilities

• Act as a subject matter expert, driving quality improvements and mentoring colleagues.
• Develop and update quality system procedures (ISO/QSR), including validation protocols, SOPs, and risk management (pFMEA).
• Oversee risk management processes and implement mitigations for product quality and safety.
• Lead Process FMEA efforts, statistical sampling plans, and DOE-based test development.
• Ensure projects comply with GLP, QSR, ISO, and regulatory requirements.
• Analyze quality metrics, identify improvement opportunities, and resolve non-conformances.
• Participate in audits and support FDA inspections, ISO certifications, and customer audits.
• Facilitate SPC implementation and recommend manufacturing process improvements.
• Provide training, mentoring, and support for junior team members.

Qualifications

• Bachelor's or higher in Engineering or Biological Sciences; 10+ years of experience in regulated industries.
• Expertise in dFMEA/pFMEA, Design Controls, SPC, and statistical sampling.
• Direct experience with ISO 13485, ISO 14971, FDA QSR, and CAPA processes.
• Preferred certifications: CQE, CQA, CRE, and Lean Six Sigma.
• Strong communication, data analysis, and technical documentation skills.
• On-site position in Boston, MA, transitioning to Braintree, MA in 2025.