Medical Device QMS Specialist — Compliance & Quality Data

Vector Surgical; Menomonee Falls (WI); On-site; USD 90,000 - 110,000; Full time

Job summary

Vector Surgical is seeking a Medical Device QMS Specialist to support the company’s quality management system in Menomonee Falls, WI. The role will execute day-to-day QMS activities, maintain records, and coordinate quality processes across Manufacturing, Engineering, and external suppliers to ensure regulatory compliance.

The ideal candidate has a Bachelor's degree in a scientific field, at least 3 years of experience in QA/QMS within regulated industries, and strong analytical, documentation,

Qualifications

• Bachelor's degree in engineering, life sciences, chemistry, or microbiology with lab training
• Minimum 3 years in QA/QMS in regulated industries (ideally medical devices or pharma)
• Hands-on lab experience in microbiological and physical/chemical testing
• Experience supporting manufacturing and engineering in a regulated device environment
• Internal Auditor training or CQE desirable

Responsibilities

• Maintain and improve ISO 13485/QMS with FDA compliance
• Prepare metrics, dashboards for reviews and maintain records
• Coordinate document control and batch documentation review
• Perform QC testing and analyze quality data for trends
• Coordinate complaints, CAPAs, SCARs, and supplier quality activities
• Assist internal/external audits and regulatory inspections

Skills

Quality Management System

FDA/ISO Regulatory

Data Analysis

Documentation & Records

CAPA & Nonconformances

Audits & Compliance

QC Instrumentation

Cross-functional Collaboration

Education

Bachelor's degree in Engineering/Life Sciences/Chemistry/Microbiology

Tools

eQMS software

ERP systems

Job description

Vector Surgical is seeking a Medical Device QMS Specialist to support the company’s quality management system in Menomonee Falls, WI. The role will execute day-to-day QMS activities, maintain records, and coordinate quality processes across Manufacturing, Engineering, and external suppliers to ensure regulatory compliance.

The ideal candidate has a Bachelor's degree in a scientific field, at least 3 years of experience in QA/QMS within regulated industries, and strong analytical, documentation,