Medical Device QA Associate: Quality & Compliance

Viscot Medical; Denville (NJ); On-site; USD 65,000 - 90,000; Full time

Job summary

Viscot Medical in Denville, NJ is seeking a proactive QA Associate to ensure products meet stringent quality standards and regulatory requirements. This in-person role supports our manufacturing team and is part of a fast-paced environment where quality drives every process.

You will manage document control, CAPA, and supplier/audit activities, contribute to continuous improvement, and grow with company-sponsored ASQ/RAPS training.

Qualifications

• Bachelor's degree in a technical or scientific field required.
• 2-4 years in Quality Assurance within a regulated industry.
• Strong written, verbal and organizational skills.

Responsibilities

• Revise and control changes to the QMS and ensure GDP compliance.
• Maintain quality records per procedures.
• Author, edit, and review quality documents.
• Support internal and external audits under the Quality Manager.
• Support design and risk file documentation in the QMS.
• Maintain CAPA process as CAPA Manager.
• Assist in responding to customer document requests.
• Learn products to become SME on packaging and labeling.
• Assist sampling and test methods for QC inspections.
• Analyze data using quality tools (Pareto, fishbone).
• Support IQ/OQ/PQ validations and testing procedures.
• Present data for quality reports.
• Support the Quality Manager with audits and data analysis.
• Support quality initiatives and process improvements.

Skills

Written English

Verbal communication

Organizational skills

UI familiarity

Education

Bachelor's degree in technical/scientific field

Tools

Microsoft Office Suite

Visio

Job description

Viscot Medical in Denville, NJ is seeking a proactive QA Associate to ensure products meet stringent quality standards and regulatory requirements. This in-person role supports our manufacturing team and is part of a fast-paced environment where quality drives every process.

You will manage document control, CAPA, and supplier/audit activities, contribute to continuous improvement, and grow with company-sponsored ASQ/RAPS training.