Quality Systems Engineer: Lead QMS, CAPA & Audit Excellence

VulcanForms Inc.; Harvard (MA); On-site; USD 75,000 - 104,000; Full time

Benefits offered by this job

Competitive salary and equity

Comprehensive benefits including 401(k

Paid time off

Job summary

VulcanForms Inc. is seeking a Quality Systems Engineer to establish and maintain the QMS in line with FDA, ISO13485, and AS9100/ISO9001 requirements.

You will write procedures, manage document control, and ensure compliant quality processes across the organization. You will support NCR, CAPA, and internal audit programs, while collaborating with multiple functions to drive improvements and robust change management.

Qualifications

• 3+ years in medical device or aerospace with FDA/ISO13485/AS9100/ISO9001 experience.
• Experience writing QMS procedures.
• Experience with NCR and CAPA processes.
• Excellent communication, interpersonal and leadership skills.
• Experience evaluating quality metrics and KPIs.

Responsibilities

• Establish and maintain a Quality System compliant with regulatory requirements.
• Write, review, and approve changes to QMS documentation.
• Support NCR, CAPA, internal audits, and training programs.
• Track and trend quality metrics/KPIs and drive data-driven improvements.
• Lead or support QS projects and cross-functional activities.

Skills

Quality systems

CAPA

NCR

Document control

Regulatory requirements

Job description

VulcanForms Inc. is seeking a Quality Systems Engineer to establish and maintain the QMS in line with FDA, ISO13485, and AS9100/ISO9001 requirements.

You will write procedures, manage document control, and ensure compliant quality processes across the organization. You will support NCR, CAPA, and internal audit programs, while collaborating with multiple functions to drive improvements and robust change management.