Medical Device QMS Specialist: Quality & Compliance

Vector Surgical, LLC; Menomonee Falls (WI); On-site; USD 70,000 - 110,000; Full time

Job summary

Vector Surgical, LLC is seeking an outstanding Medical Device Quality Management System Specialist in Menomonee Falls, WI. The role supports the QMS implementation, maintenance, and continuous improvement across QA, producing quality records and coordinating audits.

The specialist collaborates with Manufacturing, Engineering, and suppliers to ensure compliance with ISO 13485, FDA regulations, and company procedures, while performing quality control testing and data analysis.

Qualifications

• BS degree with hands-on QA/QMS in regulated industry.
• Experience with ISO 13485 and FDA requirements.
• Laboratory testing and QC data handling experience.
• Audit support and supplier quality familiarity.

Responsibilities

• Maintain and improve the QMS in line with regulations.
• Prepare quality metrics, trend analyses, dashboards, and reviews.
• Manage documentation, batch records, and control activities.
• Coordinate CAPA, NCRs, SCARs, and supplier quality.

Skills

QMS

ISO 13485 familiarity

FDA QSR 21 CFR 820

Laboratory QC testing

Data analysis & reporting

Document control

CAPA & nonconformances

eQMS & ERP systems

Technical writing

Attention to detail

Cross-functional collaboration

Independent work & teamwork

Education

Bachelor's degree in Engineering/Life Sciences/ Chemistry

Minimum 3 years QA/QMS in regulated industry

Lab experience with microbiology/physical testing

Auditor training or CQE desirable

Tools

eQMS software

ERP systems

Laboratory instruments

Regulatory databases

Job description

Vector Surgical, LLC is seeking an outstanding Medical Device Quality Management System Specialist in Menomonee Falls, WI. The role supports the QMS implementation, maintenance, and continuous improvement across QA, producing quality records and coordinating audits.

The specialist collaborates with Manufacturing, Engineering, and suppliers to ensure compliance with ISO 13485, FDA regulations, and company procedures, while performing quality control testing and data analysis.