Site Quality Assurance Engineer (Medtech)

TL;DR

Site Quality Assurance Engineer (Medtech): Supporting the quality assurance organization by monitoring production performance, troubleshooting quality issues, and interfacing with R&D for new product introductions with an accent on regulatory compliance and process improvement. Focus on leading product complaint investigations, managing CAPA programs, and ensuring adherence to ISO 13485 and FDA QSR standards.

Location: Must be based in Pawtucket, RI

Salary: $75,000–$95,000

Company

hirify.global Corporation develops innovative lifesaving medical devices and software solutions for EMS, hospital, and military customers globally.

What you will do

• Lead product complaint investigations from receipt to resolution.
• Monitor production quality performance to identify and implement improvement opportunities.
• Support manufacturing process validations and change control activities.
• Participate in Material Review Board activities and resolve product nonconformities.
• Ensure compliance with Quality System SOPs, GMP, ISO, and FDA requirements.
• Engage in internal and external audits as a subject matter expert.

Requirements

• BS degree in a science or engineering related discipline.
• 3+ years of related experience in a regulated environment, preferably medical devices.
• Proficiency in statistical analysis and problem-solving.
• Experience with ISO 13485, ISO 14971, and FDA QSR.
• Strong organizational skills with the ability to manage multiple tasks.
• Excellent verbal and written communication skills.

Nice to have

• ASQ Certified Quality Engineer certification.

Culture & Benefits

• Comprehensive benefits plans including health and wellness programs.
• Opportunity to work on lifesaving medical technology.
• Fast-growing company with a focus on innovation and entrepreneurial spirit.
• Eligible for an annual bonus in accordance with the company plan.