Quality Systems Engineer

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

Job Purpose

• As a Quality Systems Engineer, you will be responsible for helping to ensure the QMS is established and maintained in accordance with applicable regulatory requirements. A candidate must have knowledge of quality systems, CAPA, NCR, and document control. This position is responsible for writing and updating QMS procedures and is accountable for ensuring quality processes are executed compliantly. QMS compliance will be met by ensuring that activities previously noted are conducted according to prescribed procedures, policies, and regulations.

Key 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

Qualifications

• 3+ years’ experience working in the medical device or aerospace fields with experience in 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

Preferred Qualifications

• Experience with Start-ups
• Experience in audit support
• Experience leading and influencing across functional groups and leadership levels

VulcanFormsoffers a competitive salary and equitypackage.Actual compensation is based on factors such as the candidate’s skills, qualifications, and experience.In addition,VulcanFormsprovides comprehensive benefits including medical, dental, vision, and life insurance; generous paid time off; and a 401(k) plan with companymatch.

The annual base salary range for this position is $75,413.00 to $103,692.00.