Senior Quality Engineer (MedTech)

TL;DR

Senior Quality Engineer (MedTech): Developing and maintaining robust quality systems for healthcare technologies with an accent on regulatory compliance and continuous improvement. Focus on leading root cause investigations, executing validation strategies, and ensuring products meet FDA and ISO standards.

Location: Onsite in Danvers, MA. Must possess unrestricted U.S. work authorization.

Salary: $98,400 - $147,600

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life.

What you will do

• Lead the development and maintenance of quality standards and protocols across manufacturing and product development.
• Collaborate with R&D, Manufacturing, and Process Engineering to integrate quality requirements into products.
• Design and evaluate inspection methods, testing equipment, and measurement systems.
• Analyze quality data using statistical techniques to drive root cause investigations and risk mitigation.
• Manage CAPA, nonconformance, complaint, and audit activities to ensure regulatory compliance.
• Mentor cross-functional teams on quality principles, tools, and industry best practices.

Requirements

• Bachelor’s degree with 4+ years of relevant experience or an Advanced degree with 2+ years.
• Unrestricted U.S. work authorization is required (Sponsorship is only offered for Principal-level roles and above).
• Experience in medical device or FDA-regulated manufacturing environments.
• Deep understanding of ISO 13485, FDA Quality System Regulations, and risk management.
• Proficiency in statistical analysis and problem-solving methodologies.

Nice to have

• ASQ Certified Quality Engineer (CQE) or equivalent certification.
• Strong project leadership and cross-functional collaboration skills.

Culture & Benefits

• Comprehensive health, dental, and vision insurance including HSA and FSA options.
• 401(k) plan with employer contribution and matching.
• Short-term incentive plan (hirify.global Incentive Plan).
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and global well-being program (Simple Steps).
• Paid time off and holidays.