Quality Systems Engineer — QMS, CAPA, Audits + Equity

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

Benefits offered by this job

Medical, dental, vision, and life保险

401(k) plan with company match

Generous paid time off

Job summary

VulcanForms Inc. is seeking a Quality Systems Engineer to establish and maintain the QMS in compliance with FDA regulations and ISO standards.

You will write and update QMS procedures, support NCR, CAPA, internal audits, and training programs, and drive data‑driven improvements across quality metrics. The role requires 3+ years in medical device or aerospace settings, strong communication and leadership, and a track record of quality system projects and cross‑functional collaboration.

Qualifications

• 3+ years’ experience in medical device or aerospace with FDA regulatory requirements and ISO 13485.
• Experience in writing QMS procedures.
• Experience in NCR and CAPA.
• Excellent communication, interpersonal and leadership skills.
• Experience evaluating quality metrics and KPIs.

Responsibilities

• Ensure that a Quality System is established and maintained to the highest levels of accordance with applicable regulatory requirements.
• Write, review, and approve the release of changes to QMS documentation.
• Support the NCR program.
• Support the internal audit program.
• Support the CAPA program.
• Support the preparation of Management Review.
• Support the QMS training program.
• Work with other functions to ensure accurate, complete, and efficient change processing and document control activities.
• Support the tracking and trending of quality metrics/KPIs (e.g., CAPAs, NCs, SCARs, complaints, deviations, internal audit findings, calibration, etc.).
• Identify areas of improvement through data-driven trending and bring solutions to management.
• Lead/support Quality System projects effectively.
• Develop innovative and practical solutions to complex and unique process problems and systematic improvements through the use of best practices.
• Identify/escalate any compliance issues and their potential impact and provide potential solutions/actions so that they can be effectively resolved.
• Support audits and inspections as needed (e.g., coordinate preparation activities, FR/BR support, track resolution activities).
• Lead or support additional projects as assigned by QS Leadership.

Skills

Quality systems

Leadership

Communication

Documentation

Job description

VulcanForms Inc. is seeking a Quality Systems Engineer to establish and maintain the QMS in compliance with FDA regulations and ISO standards.

You will write and update QMS procedures, support NCR, CAPA, internal audits, and training programs, and drive data‑driven improvements across quality metrics. The role requires 3+ years in medical device or aerospace settings, strong communication and leadership, and a track record of quality system projects and cross‑functional collaboration.