Quality Assurance Assistant

Quality Associate

Location: Onsite in Sturtevant, WI

Duration: 6 month contract

Job Summary:

Our client is seeking a Quality Associate I to support quality investigations, documentation, and compliance activities within the company’s Quality Management System (QMS). This role will assist in maintaining quality records, tracking corrective and preventive actions (CAPA), and ensuring compliance with regulatory requirements.

This is an entry-level or early-career quality role, ideal for candidates with a background in Quality Assurance, Engineering, or a regulated industry looking to gain hands-on experience in a medical device or pharmaceutical environment.

Key Responsibilities:

• Assist with quality investigations by gathering data, reviewing records, and summarizing findings.
• Support CAPA documentation and tracking, ensuring all actions are recorded accurately and completed on time.
• Review and update quality documents, including standard operating procedures (SOPs) and reports.
• Prepare reports and summaries for audits, CAPA reviews, and regulatory inspections.
• Perform data entry and analysis related to quality trends, non-conformances, and process deviations.
• Collaborate with cross-functional teams to track and resolve quality-related issues.
• Ensure compliance with FDA, ISO 13485, and company quality policies through accurate documentation and record-keeping.

Qualifications:

• Bachelor’s degree in Physical Science, Engineering, or equivalent experience.
• Experience in Quality Assurance or a regulated industry (medical devices, pharmaceuticals, biotech, or manufacturing) preferred.
• Strong technical writing and problem-solving skills.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint) and familiarity with QMS software.
• Attention to detail with strong organizational skills.
• Vision Assessment required: 20/20 near visual acuity & acceptable color vision.