Quality Assurance Associate

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 managing Quality Processes such as Document Control, Complaint Handling, and CAPAs Experience with international regulations of medical devices.

Pay:

$70,000.00 - $80,000.00 per year Application Question(s): Do you now or will you in the future require employer H1-B visa sponsorship?

Work Location:

In person