Quality Systems Engineer: Compliance Leader, Equity & PTO

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Paid time off

401(k) matching

Job summary

VulcanForms Inc. in Harvard, MA, seeks a Quality Systems Engineer to establish and maintain the QMS in line with regulatory requirements. You will write and update QMS procedures and ensure quality processes are executed compliantly.

The role requires 3+ years in medical device or aerospace with FDA/ISO13485 experience and strong communication and leadership skills. VulcanForms offers comprehensive benefits including medical, dental, vision, life insurance; generous PTO; and a 401(k) with

Qualifications

• 3+ years’ experience in the medical device or aerospace fields with FDA regulatory requirements, ISO 13485, and/or AS9100/ISO9001.
• Experience in writing QMS procedures.
• Experience in NCR and CAPA.
• Excellent communication, interpersonal and leadership skills.
• Experience working with and evaluating Quality metrics and KPIs.

Responsibilities

• Establish and maintain a Quality System to comply with regulatory requirements.
• Write, review, and approve changes to QMS documentation.
• Support the NCR program.
• Support the internal audit program.
• Support the CAPA program.
• Support Management Review preparation.
• Support the QMS training program.
• Collaborate with functions to ensure proper change processing and document control.
• Track and trend quality metrics/KPIs (CAPAs, NCs, SCARs, complaints, deviations, internal audit findings, calibration).
• Identify improvement opportunities through data-driven trending and bring solutions to management.
• Lead or support QS projects.
• Develop innovative solutions to complex process problems using best practices.
• Identify/escalate compliance issues and propose solutions.
• Support audits and inspections as needed.

Skills

Quality systems

QMS procedures

NCR

CAPA

Quality metrics

Leadership

Communication

Job description

VulcanForms Inc. in Harvard, MA, seeks a Quality Systems Engineer to establish and maintain the QMS in line with regulatory requirements. You will write and update QMS procedures and ensure quality processes are executed compliantly.

The role requires 3+ years in medical device or aerospace with FDA/ISO13485 experience and strong communication and leadership skills. VulcanForms offers comprehensive benefits including medical, dental, vision, life insurance; generous PTO; and a 401(k) with