Quality Assurance Associate

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

Work Location: In person in Denville, NJ. We are moving locations from East Hanover, NJ to Denville, NJ in Spring 2026.

OVERVIEW

We are seeking a proactive and detail-oriented Quality Assurance Associate to support our dynamic manufacturing team. In this vital role, you will ensure that all products meet rigorous quality standards and comply with industry regulations. Your dedication to precision and continuous improvement will help uphold our commitment to delivering exceptional quality to our customers. This position offers an exciting opportunity to contribute to a fast-paced environment where quality is at the forefront of every process.

RESPONSIBILITIES

Document Control:

• Revise, monitor and control changes to QMS through our electronic system to ensure communication and training is provided while ensuring compliance to GDP.
• Maintain quality records in accordance to documented procedures.
• Author, edit, and review quality documents.
• Support internal and external audit activities under guidance of Quality Manager.
• Support Engineering in advising and the documenting of Design and Risk files in the QMS.
• Maintain CAPA process as CAPA Manager.

Quality Assurance:

• Assist in supporting Sales and Customer Service in providing customers with document requests.
• Learn Viscot Medical products to become Subject Matter Expert on product, product packaging and labeling.
• Support sampling and test methods for Incoming, WIP, and Outgoing QC Inspections.
• Support RCAs and analyze data using Quality Tools (Pareto and Fishbone).
• Support IQ/OQ/PQ Validations and internal testing procedures.
• Present data to support Quality reports.
• Support Quality Manager as needed for reports, audits, testing and data analysis.

Continuous Improvement:

• Support Quality initiatives and other improvement activities within Viscot Medical.
• Viscot Medical supports and encourages professional growth and training through attaining ASQ or RAPS certifications (company sponsored)

REQUIREMENTS

• Bachelor’s Degree in a technical or scientific discipline
• 2-4 years of experience in Quality Assurance in a regulated industry
• Strong written, verbal and organizational skills.
• Strong Microsoft Suite user for Word, Excel, PowerPoint, and Visio.
• Demonstratable comfort level using and learning to use computer/electronic devices at the user interface (UI) level.

PREFERRED SKILLS AND QUALIFICATIONS

• Experience in Medical Device: 21 CFR Part 820, ISO 13485: 2016
• CQE or CQA designation from ASQ
• Experience managingQuality Processes such as Document Control, Complaint Handling, and CAPAs
• Experience with international regulations of medical devices.