Senior Quality Engineer (Medtech)

TL;DR

Senior Quality Engineer (Medtech): Developing and maintaining robust quality systems for medical device manufacturing with an accent on regulatory compliance, risk management, and continuous improvement. Focus on leading cross-functional investigations, driving CAPA initiatives, and ensuring product safety through rigorous validation and statistical analysis.

Location: Must be based onsite in Danvers, MA (5 days per week)

Salary: $98,400–$147,600 USD

Company

A global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life through innovative engineering solutions.

What you will do

• Lead the development and maintenance of quality standards and protocols across manufacturing and product development.
• Partner with R&D, Operations, and Engineering teams to integrate quality requirements into product lifecycles.
• Design and execute inspection, testing, and validation strategies to ensure regulatory compliance.
• Analyze quality data using statistical techniques to drive root cause investigations and risk mitigation.
• Manage CAPA, nonconformance, and audit activities to ensure effective corrective and preventive actions.
• Mentor engineers on quality principles, tools, and best practices.

Requirements

• Bachelor’s Degree with at least 4 years of relevant experience OR Advanced degree with 2+ years of experience.
• Must possess unrestricted U.S. work authorization at the time of hire.
• Strong understanding of quality systems, risk management, and validation processes.
• Knowledge of FDA Quality System Regulations and ISO 13485 standards.
• Proficiency in statistical analysis and problem-solving methodologies.
• Ability to work onsite in Danvers, MA, 5 days per week.

Nice to have

• Experience in medical device or FDA-regulated manufacturing environments.
• ASQ Certified Quality Engineer (CQE) or equivalent certification.

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401(k) plan with employer contribution and match.
• Paid time off and paid holidays.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and well-being programs.
• Supportive environment focused on healthcare access and equity.