Senior MedTech QA Engineer – Regulatory & QMS Lead

MedAcuity; Lowell (MA); On-site; USD 125,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Dental and vision insurance

401(k) matching

Life and disability insurance

HRA and FSA

Job summary

MedAcuity, Inc. seeks a Senior Quality Assurance Engineer for the MedTech space, focusing on remediating legacy quality systems and ensuring compliant project execution. You will audit processes, develop QMS procedures, and align with 21 CFR Part 820, ISO 13485, and ISO 14971 standards.

The role includes CAPA processing, risk analysis, and cross-functional training, with competitive compensation and comprehensive benefits.

Qualifications

• Bachelor's degree in a STEM field or equivalent experience in a regulated quality environment.
• 8+ years in QA/regulatory within medical devices or software-enabled devices.
• Strong knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Experience with CAPA processes, corrective actions, and risk management.

Responsibilities

• Lead or participate in quality management system assessments related to medical device software.
• Author and improve QMS documents, SOPs and project quality plans.
• Ensure conformance to Design Controls, Risk Management (ISO 14971) and related standards.
• Support internal and external audits and regulatory inspections.
• Perform root cause analysis and drive CAPA execution across teams.
• Develop training materials for engineering, quality and leadership audiences.
• Collaborate with project teams and clients to ensure compliant project execution.
• Provide QA/regulatory technical support to product development and service activities.

Skills

Regulatory compliance

CAPA

Root Cause Analysis

Quality Assurance

Software validation

Education

Bachelor's degree in Computer Science

Bachelor's degree in Electrical Engineering

Tools

MasterControl

Arena

Veeva

eQMS

Job description

MedAcuity, Inc. seeks a Senior Quality Assurance Engineer for the MedTech space, focusing on remediating legacy quality systems and ensuring compliant project execution. You will audit processes, develop QMS procedures, and align with 21 CFR Part 820, ISO 13485, and ISO 14971 standards.

The role includes CAPA processing, risk analysis, and cross-functional training, with competitive compensation and comprehensive benefits.