Quality Systems Engineer, Medical Device

Job overview

The Quality Systems Engineer role is onsite in Manchester, NH. Compensation is not specified. The engineer works with cross-functional teams to maintain quality and compliance for medical-device operations. The role owns and improves quality management system processes, with particular focus on CAPA, controlled documentation, audits, and regulatory compliance. It helps identify systemic issues, verify corrective actions, and maintain audit readiness under FDA and ISO requirements.

What you'll do

• Manage CAPA from intake and triage through investigation, root-cause analysis, action planning, and effectiveness verification
• facilitate cross-functional CAPA reviews
• maintain objective evidence and traceability
• monitor CAPA trends and metrics
• develop and revise SOPs and change controls
• support QMS compliance with FDA 21 CFR Part 820 and ISO 13485
• review quality records
• conduct internal audits and support auditor training
• prepare for and support external audits.

What we're looking for

Skills & competencies

quality systems engineer

medical device

manchester nh

innotech staffing

capa

qms

fda 21 cfr part 820

iso 13485

sops

change control

internal audits

regulatory compliance

Work arrangement

• Weekend coverage required

Why this role

Requires a bachelor's or master's degree in engineering, life sciences, or a related field; three or more years in a quality systems role in a regulated industry is required.

About the employer

InnoTech Staffing is hiring for this role. Industry: Employment Placement Agencies. Sector: 56.