Quality Systems Engineer: QMS Leader for Medical Devices

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

Benefits offered by this job

Equity

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k) plan with company match

Paid time off

Job summary

VulcanForms Inc. is seeking a Quality Systems Engineer to establish and maintain the QMS in line with FDA and ISO requirements. You will write procedures, manage CAPA and NCR processes, and partner with cross-functional teams to ensure compliant quality practices.

The role includes internal audits, management review, QMS training, KPI tracking, and leading quality system projects while identifying improvements and escalating issues as needed.

Qualifications

• 3+ years' experience in medical device or aerospace with FDA/regulatory exposure.
• 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 per regulatory requirements.
• Write, review, and approve changes to QMS documentation.
• Support the NCR program
• Support the internal audit program
• Support the CAPA program
• Prepare Management Review
• Support the QMS training program
• Coordinate change processing and document control with other functions
• Track and trend quality metrics/KPIs
• Identify improvement opportunities through data-driven analysis
• Lead or support Quality System projects
• Develop practical solutions for process problems
• Escalate compliance issues and propose actions
• Support audits and inspections
• Lead or support additional QS projects

Skills

FDA regulatory

ISO 13485

AS9100/ISO9001

QMS procedures

NCR

CAPA

KPIs

leadership

communication

Job description

VulcanForms Inc. is seeking a Quality Systems Engineer to establish and maintain the QMS in line with FDA and ISO requirements. You will write procedures, manage CAPA and NCR processes, and partner with cross-functional teams to ensure compliant quality practices.

The role includes internal audits, management review, QMS training, KPI tracking, and leading quality system projects while identifying improvements and escalating issues as needed.