Engineer II, QA (Medtech)

TL;DR

Engineer II, QA (Medtech): Providing quality assurance oversight for CAPA activities and QMS maintenance in the medical device industry with an accent on root cause analysis and regulatory compliance. Focus on leading failure investigations, ensuring adherence to ISO 13485 and FDA requirements, and driving continuous improvement.

Location: Hybrid in Merrimack, NH, US (1-2 days at home)

Salary: $90K - $110K + 8% STIP

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.

What you will do

• Lead CAPA Request and CAPA teams through the full process to ensure successful and timely completion.
• Facilitate failure investigations and lead root cause analyses to address underlying issues.
• Review and process CAPA documentation within electronic systems per procedures and regulations.
• Maintain the Quality Management System (QMS) in line with ISO 13485, EU-MDR, and FDA requirements.
• Support external audits as a scribe, backroom technical support, or through file preparation.
• Perform data mining and interpret statistics to prepare trending and metrics documentation.

Requirements

• Bachelor's degree in an engineering or scientific discipline (e.g., Chemistry, Biology, Physics).
• 2+ years of quality experience in the medical device industry or other highly regulated industry.
• Proven experience performing root cause investigations.
• Knowledge of Quality Systems, ISO 13485, and FDA requirements.
• Proficiency in MS Office applications (Word, Excel, PowerPoint, Outlook, Teams).

Culture & Benefits

• Comprehensive health, dental, and vision insurance benefits.
• 401k plan with company match.
• Paid Time Off and parental/caregiver leave.
• Wellness initiatives and health assistance resources.
• Tuition reimbursement and professional development opportunities.
• Short and long-term disability benefits.